Biolox® delta · 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.

76 linked reportsInjury 70Malfunction 6

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	13	2.72
2019-02	1	2.45
2019-03	3	2.79
2019-04	2	2.65
2019-05	2	2.07
2019-06	0	1.85
2019-07	3	1.73
2019-08	2	2.19
2019-09	0	2.2
2019-10	0	2.5
2019-11	0	2.2
2019-12	3	2.55
2020-01	2	3.08
2020-02	0	2.52
2020-03	1	3.17
2020-04	0	2.37
2020-05	0	2.26
2020-06	1	2.13
2020-07	2	2.62
2020-08	0	2.21
2020-09	0	2.8
2020-10	0	2.76
2020-11	0	2.4
2020-12	1	2.47
2021-01	0	2.52
2021-02	0	2.24
2021-03	0	2.2
2021-04	0	2.17
2021-05	0	2.19
2021-06	0	2.49
2021-07	0	2.58
2021-08	1	2.56
2021-09	0	2.75
2021-10	0	2.46
2021-11	1	2.22
2021-12	1	2.46
2022-01	0	2.31
2022-02	0	2.33
2022-03	0	2.38
2022-04	1	2.3
2022-05	1	2.46
2022-06	0	2.32
2022-07	0	2.32
2022-08	0	2.33
2022-09	1	2.44
2022-10	1	2.4
2022-11	0	2.48
2022-12	0	2.48
2023-01	1	2.63
2023-02	2	2.34
2023-03	1	2.47
2023-04	1	2.44
2023-05	1	2.35
2023-06	1	2.45
2023-07	0	2.31
2023-08	1	2.02
2023-09	0	2.04
2023-10	2	1.8
2023-11	0	1.78
2023-12	0	1.89
2024-01	0	1.84
2024-02	0	2.21
2024-03	1	2.01
2024-04	0	1.91
2024-05	0	2.24
2024-06	0	2
2024-07	2	1.82
2024-08	0	2.05
2024-09	1	2.05
2024-10	0	1.87
2024-11	1	1.99
2024-12	1	1.71
2025-01	0	2.18
2025-02	1	1.66
2025-03	2	1.85
2025-04	0	1.95
2025-05	0	1.94
2025-06	0	1.97
2025-07	1	1.92
2025-08	2	1.94
2025-09	0	1.75
2025-10	2	1.84
2025-11	6	1.9
2025-12	0	1.99
2026-01	2	2.04
2026-02	0	1.83
2026-03	0	1.98
2026-04	0	2.12
2026-05	0	1.92
2026-06	1	1.88

This device (reports/month)Average device in LZO (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
2026-06-30	0009613350-2026-00339	Injury	Available	exact di
2026-01-13	0009613350-2026-00011	Malfunction	Available	catalog number
2025-11-28	0009613350-2025-00900	Injury	Available	catalog number
2025-11-24	0009613350-2025-00884	Injury	Available	exact di
2025-11-07	0009613350-2025-00864	Injury	Available	catalog number
2025-11-04	0009613350-2025-00854	Injury	Available	exact di
2025-10-28	0009613350-2025-00817	Injury	Available	catalog number
2025-08-26	0009613350-2025-00676	Injury	Available	catalog number
2025-07-15	0009613350-2025-00595	Injury	Available	exact di
2025-03-10	0009613350-2025-00096	Injury	Available	exact di
2025-03-03	0009613350-2025-00089	Injury	Available	exact di
2025-02-11	0009613350-2025-00052	Injury	Available	exact di
2024-12-30	0009613350-2024-00637	Injury	Available	exact di
2024-11-05	0009613350-2024-00521	Injury	Available	exact di
2024-09-12	0009613350-2024-00448	Injury	Available	exact di

Showing the most recent 58 of 76 linked reports.

Showing 1–15 of 58

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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