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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.8 |
| 2019-02 | 0 | 1.5 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 1.57 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 1.8 |
| 2019-07 | 0 | 1.43 |
| 2019-08 | 0 | 1.5 |
| 2019-09 | 0 | 1.56 |
| 2019-10 | 0 | 1.77 |
| 2019-11 | 0 | 1.17 |
| 2019-12 | 0 | 1.67 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 3 |
| 2020-03 | 0 | 2.7 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1 |
| 2020-06 | 0 | 2.67 |
| 2020-07 | 0 | 3.75 |
| 2020-08 | 0 | 2.73 |
| 2020-09 | 0 | 1.67 |
| 2020-10 | 0 | 1.67 |
| 2020-11 | 0 | 3.11 |
| 2020-12 | 0 | 1.75 |
| 2021-01 | 0 | 1.86 |
| 2021-03 | 0 | 1.86 |
| 2021-04 | 0 | 1.67 |
| 2021-05 | 0 | 1.75 |
| 2021-06 | 0 | 3.33 |
| 2021-07 | 0 | 1.5 |
| 2021-08 | 0 | 2.5 |
| 2021-09 | 0 | 2.33 |
| 2021-10 | 0 | 2.5 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1.5 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 4 |
| 2022-07 | 1 | 1 |
| 2022-08 | 0 | 2.75 |
| 2022-09 | 0 | 1.5 |
| 2022-10 | 0 | 2.5 |
| 2022-11 | 0 | 1.8 |
| 2023-01 | 0 | 4.5 |
| 2023-02 | 0 | 3 |
| 2023-03 | 0 | 2 |
| 2023-04 | 1 | 1 |
| 2023-05 | 0 | 3 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 2.67 |
| 2023-08 | 0 | 1.67 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 2.71 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1.67 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 2 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1.75 |
| 2024-10 | 0 | 1.83 |
| 2024-11 | 0 | 2 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 1.6 |
| 2025-03 | 0 | 1.5 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 1.5 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1.67 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 2.22 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1.5 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 1.67 |
| 2026-05 | 0 | 1.5 |
| 2026-06 | 0 | 2 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-11-29 | Z-1052-2018 | Class II | Terminated | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE. | 13,227 in total | clearance family |
| 2017-11-29 | Z-1053-2018 | Class II | Terminated | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE. | 13,227 in total | clearance family |
| 2016-01-11 | Z-0837-2016 | Class II | Terminated | LDPE bag containing the implant adheres to the highly polished implant surface.Distribution: Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada | 5103 | clearance family |
| 2014-07-30 | Z-2545-2014 | Class II | Terminated | Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.Distribution: Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK. | 15 units | clearance family |
| 2013-08-30 | Z-0077-2014 | Class II | Terminated | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula. | 5103 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-04-11 | 0001822565-2023-00981 | Injury | Available | exact di |
| 2022-07-06 | 0001822565-2022-01897 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
- K173057
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 |
|---|---|---|---|---|
| 2022-07-27 | NAI | No action indicated | Zimmer, Inc. | 0 |
| 2022-07-27 | NAI | No action indicated | Zimmer, Inc. | 0 |
| 2020-10-01 | NAI | No action indicated | Zimmer Manufacturing B.V. | 0 |
| 2017-10-16 | VAI | Voluntary action indicated | Zimmer, Inc. | 8 |
| 2017-10-16 | VAI | Voluntary action indicated | Zimmer, Inc. | 8 |
| 2017-09-01 | NAI | No action indicated | Zimmer Trabecular Metal Technology, Inc. | 0 |
| 2017-07-27 | VAI | Voluntary action indicated | ZIMMER ORTHOPEDIC MFG LTD | 3 |
| 2017-07-20 | VAI | Voluntary action indicated | Zimmer Manufacturing B.V. | 3 |
| 2016-05-27 | WL | Warning Letter | Orthosoft, Inc. | — |
| 2016-05-23 | VAI | Voluntary action indicated | Zimmer Surgical Inc | 4 |
| 2015-11-20 | OAI | Official action indicated | Zimmer, Inc. | 10 |
| 2015-11-20 | OAI | Official action indicated | Zimmer, Inc. | 10 |
| 2015-11-17 | VAI | Voluntary action indicated | Zimmer Manufacturing B.V. | 4 |
| 2015-05-11 | VAI | Voluntary action indicated | Zimmer Trabecular Metal Technology, Inc. | 3 |
| 2014-10-16 | VAI | Voluntary action indicated | ZIMMER ORTHOPEDIC MFG LTD | 2 |
| 2014-06-11 | OAI | Official action indicated | Zimmer Manufacturing B.V. | 9 |
| 2014-05-28 | OAI | Official action indicated | Zimmer, Inc. | 12 |
| 2014-05-28 | OAI | Official action indicated | Zimmer, Inc. | 12 |
| 2014-02-07 | VAI | Voluntary action indicated | Zimmer, Inc. | 2 |
| 2014-02-07 | VAI | Voluntary action indicated | Zimmer, Inc. | 2 |
| 2013-08-19 | OAI | Official action indicated | Zimmer, Inc. | 0 |
| 2012-09-19 | WL | Warning Letter | Zimmer Manufacturing B.V. | — |
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