Oxford Partial Knee System · recalls, adverse events, clearances

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.

44 linked reportsInjury 44

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1.9
2019-02	0	1.67
2019-03	1	1.12
2019-04	0	1.52
2019-05	2	1.23
2019-06	0	1.89
2019-07	0	2.52
2019-08	1	2
2019-09	0	2.33
2019-10	2	1.37
2019-11	0	1.77
2019-12	0	2.13
2020-01	0	1.5
2020-02	0	1.5
2020-03	0	1.82
2020-04	0	1.73
2020-05	0	1.67
2020-06	0	1.82
2020-07	0	2.14
2020-08	0	1.55
2020-09	0	1.93
2020-10	0	1.78
2020-11	2	1.3
2020-12	1	2.29
2021-01	0	2
2021-02	1	1.25
2021-03	0	1.38
2021-04	0	1.55
2021-05	0	2.31
2021-06	0	1.85
2021-07	0	2.29
2021-08	0	1.8
2021-09	0	1.84
2021-10	0	1.9
2021-11	0	2.11
2021-12	0	1.63
2022-01	0	2.29
2022-02	0	2.27
2022-03	0	1.6
2022-04	0	1.85
2022-05	0	2
2022-06	0	2.53
2022-07	0	2.23
2022-08	0	2.1
2022-09	0	2.2
2022-10	0	2.29
2022-11	2	2
2022-12	0	2
2023-01	0	2.36
2023-02	0	2.78
2023-03	2	1.92
2023-04	0	3.92
2023-05	0	3
2023-06	0	2.23
2023-07	2	2.19
2023-08	0	2.5
2023-09	0	2.17
2023-10	0	2.1
2023-11	2	2.67
2023-12	2	2.63
2024-01	0	1.71
2024-02	0	1.19
2024-03	0	2.22
2024-04	0	2.33
2024-05	2	1.92
2024-06	0	2.75
2024-07	4	2.33
2024-08	2	2.08
2024-09	0	2
2024-10	1	1.78
2024-11	2	2.44
2024-12	0	1.8
2025-01	0	2.2
2025-02	0	2.25
2025-03	0	1.89
2025-04	1	1.38
2025-05	2	1.56
2025-06	0	1.83
2025-07	2	2.08
2025-08	2	1.67
2025-09	0	1.4
2025-10	0	2.2
2025-11	2	2
2025-12	0	2.9
2026-01	0	2.38
2026-02	2	2.71
2026-03	0	2
2026-04	2	3.36
2026-05	0	1.67
2026-06	0	1.83

This device (reports/month)Average device in NRA (reports/device/month)

Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-04-08	3002806535-2026-00138	Injury	Available	catalog number
2026-02-11	3002806535-2026-00074	Injury	Available	catalog number
2025-11-03	3002806535-2025-00525	Injury	Available	catalog number
2025-08-19	3002806535-2025-00350	Injury	Available	catalog number
2025-07-15	3002806535-2025-00266	Injury	Available	catalog number
2025-05-07	3002806535-2025-00181	Injury	Available	catalog number
2025-04-16	3002806535-2025-00163	Injury	Available	catalog number
2024-11-11	3002806535-2024-00420	Injury	Available	catalog number
2024-10-17	3002806535-2024-00398	Injury	Available	exact di
2024-08-13	3002806535-2024-00281	Injury	Available	catalog number
2024-07-25	3002806535-2024-00271	Injury	Available	catalog number
2024-07-02	3002806535-2024-00242	Injury	Available	catalog number
2024-05-02	3002806535-2024-00160	Injury	Available	catalog number
2023-12-19	3002806535-2023-00448	Injury	Available	catalog number
2023-11-02	3002806535-2023-00362	Injury	Available	catalog number

Showing the most recent 26 of 44 linked reports.

Showing 1–15 of 26

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2017-08-03	VAI	Voluntary action indicated	Biomet UK Ltd.	4
2015-03-18	VAI	Voluntary action indicated	Biomet UK Ltd.	2

Similar devices