Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
50 linked reportsInjury 38Malfunction 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 2.03 |
| 2019-02 | 0 | 2.07 |
| 2019-03 | 1 | 1.68 |
| 2019-04 | 2 | 2.01 |
| 2019-05 | 1 | 1.83 |
| 2019-06 | 2 | 2.19 |
| 2019-07 | 0 | 2.04 |
| 2019-08 | 1 | 2.24 |
| 2019-09 | 1 | 2.01 |
| 2019-10 | 0 | 2.44 |
| 2019-11 | 1 | 3.01 |
| 2019-12 | 1 | 2.42 |
| 2020-01 | 1 | 2.39 |
| 2020-02 | 0 | 2.82 |
| 2020-03 | 1 | 2.28 |
| 2020-04 | 1 | 2.21 |
| 2020-05 | 1 | 1.83 |
| 2020-06 | 0 | 2.09 |
| 2020-07 | 1 | 2.66 |
| 2020-08 | 0 | 2.72 |
| 2020-09 | 0 | 2.23 |
| 2020-10 | 0 | 2.94 |
| 2020-11 | 1 | 2.86 |
| 2020-12 | 0 | 2.95 |
| 2021-01 | 2 | 2.47 |
| 2021-02 | 1 | 2.45 |
| 2021-03 | 0 | 2.59 |
| 2021-04 | 0 | 2.45 |
| 2021-05 | 1 | 2.36 |
| 2021-06 | 1 | 2.18 |
| 2021-07 | 1 | 2.24 |
| 2021-08 | 0 | 1.88 |
| 2021-09 | 0 | 2.33 |
| 2021-10 | 0 | 1.96 |
| 2021-11 | 0 | 2.31 |
| 2021-12 | 1 | 2.33 |
| 2022-01 | 0 | 2.03 |
| 2022-02 | 0 | 2.38 |
| 2022-03 | 1 | 2.05 |
| 2022-04 | 0 | 2.1 |
| 2022-05 | 0 | 2.33 |
| 2022-06 | 0 | 2.03 |
| 2022-07 | 0 | 2.06 |
| 2022-08 | 0 | 2.1 |
| 2022-09 | 0 | 2.28 |
| 2022-10 | 0 | 2.2 |
| 2022-11 | 0 | 2.24 |
| 2022-12 | 1 | 1.9 |
| 2023-01 | 0 | 2.09 |
| 2023-02 | 13 | 2.23 |
| 2023-03 | 0 | 2.23 |
| 2023-04 | 0 | 2.26 |
| 2023-05 | 1 | 2.41 |
| 2023-06 | 0 | 2.26 |
| 2023-07 | 1 | 2 |
| 2023-08 | 0 | 1.71 |
| 2023-09 | 0 | 1.76 |
| 2023-10 | 0 | 1.63 |
| 2023-11 | 0 | 1.68 |
| 2023-12 | 0 | 1.7 |
| 2024-01 | 1 | 1.57 |
| 2024-02 | 0 | 1.74 |
| 2024-03 | 2 | 1.78 |
| 2024-04 | 2 | 1.64 |
| 2024-05 | 0 | 1.91 |
| 2024-06 | 0 | 1.98 |
| 2024-07 | 0 | 1.85 |
| 2024-08 | 0 | 2.31 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 1.99 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 2.09 |
| 2025-01 | 0 | 2.32 |
| 2025-02 | 0 | 1.83 |
| 2025-03 | 0 | 1.86 |
| 2025-04 | 0 | 1.66 |
| 2025-05 | 1 | 1.71 |
| 2025-06 | 1 | 1.81 |
| 2025-07 | 1 | 1.62 |
| 2025-08 | 0 | 1.63 |
| 2025-09 | 0 | 1.64 |
| 2025-10 | 0 | 1.43 |
| 2025-11 | 0 | 1.7 |
| 2025-12 | 0 | 1.66 |
| 2026-01 | 0 | 1.55 |
| 2026-02 | 0 | 1.53 |
| 2026-03 | 0 | 1.99 |
| 2026-04 | 0 | 1.75 |
| 2026-05 | 1 | 1.71 |
| 2026-06 | 0 | 1.7 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2013-11-18 | Z-0412-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0413-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0414-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0415-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0416-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0417-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0418-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0419-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0420-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
| 2013-11-18 | Z-0423-2014 | Class II | Terminated | DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.Distribution: Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK | 29,235 units in total / 2008 through November 2013 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-11 | 1818910-2026-08527 | Injury | Available | exact di |
| 2025-07-03 | 1818910-2025-11304 | Injury | Available | exact di |
| 2025-06-02 | 1818910-2025-08734 | Injury | Available | exact di |
| 2025-05-08 | 1818910-2025-07454 | Injury | Available | exact di |
| 2024-04-25 | 1818910-2024-09081 | Injury | Available | exact di |
| 2024-04-24 | 1818910-2024-08925 | Injury | Available | exact di |
| 2024-03-26 | 1818910-2024-06578 | Injury | Available | exact di |
| 2024-03-25 | 1818910-2024-06439 | Injury | Available | exact di |
| 2024-01-03 | 1818910-2024-00288 | Injury | Available | exact di |
| 2023-07-26 | 1818910-2023-15170 | Injury | Available | exact di |
| 2023-05-12 | 1818910-2023-10172 | Injury | Available | exact di |
| 2023-02-20 | 1818910-2023-04028 | Injury | Available | exact di |
| 2023-02-17 | 1818910-2023-03951 | Malfunction | Available | exact di |
| 2023-02-15 | 1818910-2023-03839 | Malfunction | Available | exact di |
| 2023-02-15 | 1818910-2023-03845 | Malfunction | Available | exact di |
Showing 1–15 of 50
Regulatory clearances
Predicate lineage
- K241000
Cited as predicate by: K253197
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-07-04 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
| 2015-01-08 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
| 2012-01-26 | VAI | Voluntary action indicated | DEPUY (IRELAND) | 1 |
| 2011-02-03 | NAI | No action indicated | DEPUY (IRELAND) | 0 |
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