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.
390 linked reportsMalfunction 386Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.25 |
| 2019-02 | 0 | 4.5 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 8 |
| 2019-05 | 0 | 2.67 |
| 2019-06 | 0 | 6 |
| 2019-07 | 0 | 3 |
| 2019-08 | 0 | 10.25 |
| 2019-09 | 0 | 23.5 |
| 2019-10 | 0 | 16.4 |
| 2019-11 | 0 | 36 |
| 2019-12 | 0 | 26.5 |
| 2020-01 | 0 | 23 |
| 2020-02 | 0 | 9.5 |
| 2020-03 | 2 | 10.33 |
| 2020-04 | 0 | 2.8 |
| 2020-05 | 28 | 15.5 |
| 2020-06 | 25 | 24 |
| 2020-07 | 1 | 3.17 |
| 2020-08 | 4 | 4.5 |
| 2020-09 | 0 | 7 |
| 2020-10 | 1 | 1.67 |
| 2020-11 | 0 | 14 |
| 2020-12 | 0 | 14 |
| 2021-01 | 0 | 3 |
| 2021-02 | 0 | 14 |
| 2021-03 | 9 | 19.67 |
| 2021-04 | 9 | 12 |
| 2021-05 | 0 | 18 |
| 2021-06 | 2 | 4 |
| 2021-07 | 20 | 20 |
| 2021-08 | 0 | 10 |
| 2021-09 | 0 | 4.5 |
| 2021-10 | 0 | 2.5 |
| 2021-11 | 0 | 3.5 |
| 2021-12 | 0 | 3 |
| 2022-01 | 0 | 1 |
| 2022-02 | 17 | 9.5 |
| 2022-03 | 0 | 2 |
| 2022-04 | 1 | 1.2 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 4 |
| 2022-07 | 0 | 2.75 |
| 2022-08 | 0 | 2 |
| 2022-09 | 1 | 1.25 |
| 2022-10 | 0 | 2.75 |
| 2022-11 | 1 | 1 |
| 2022-12 | 1 | 2.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 2 |
| 2023-04 | 0 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 2.25 |
| 2023-07 | 1 | 1.14 |
| 2023-08 | 3 | 5 |
| 2023-09 | 26 | 10 |
| 2023-10 | 0 | 1 |
| 2023-11 | 4 | 2 |
| 2023-12 | 1 | 1 |
| 2024-01 | 8 | 3.67 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 3 | 3 |
| 2024-07 | 1 | 1 |
| 2024-09 | 0 | 2.5 |
| 2024-10 | 0 | 1.25 |
| 2024-11 | 0 | 5 |
| 2024-12 | 1 | 1 |
| 2025-01 | 0 | 1.17 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1.33 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 2.67 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 1 |
| 2025-10 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-01 | 1 | 1 |
| 2026-02 | 5 | 2.67 |
| 2026-03 | 85 | 23.75 |
| 2026-04 | 108 | 55 |
| 2026-05 | 20 | 7.33 |
| 2026-06 | 1 | 1 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-03-30 | Z-1946-2026 | Class II | Open, Classified | Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NE, NM, NY, OH, OK, PA, SD, TN, TX, UT, WA, WI and the countries of Canada, Australia, New Zealand, Malaysia, EMEA, Chile. | 66960 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-30 | 0001822565-2026-02345 | Malfunction | Available | exact di |
| 2026-05-14 | 0001822565-2026-01568 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01544 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01535 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01547 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01548 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01542 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01540 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01539 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01537 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01546 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01545 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01534 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01538 | Malfunction | Available | exact di |
| 2026-05-12 | 0001822565-2026-01533 | Malfunction | Available | exact di |
Showing the most recent 200 of 390 linked reports.
Showing 1–15 of 200
Regulatory clearances
None linked.
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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