MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED,METAL/POLYMER

Catalog Number	32-422097
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is the combined initial and final.G2: foreign - event occurred in germany.The complaint can be confirmed through the returned product analysis.The tip of the device is fractured off (all returned).Visual examination of the returned product identified signs of use (dings and scratches on the posterior surface).The tip of the device is fractured off (all returned).The device has a potential field age of 9 plus years.Device examination findings were also assessed in the context of prior investigations involving the same device type and similar failure mode, specifically, distal tip fracture.In those prior investigations, detailed fracture evaluations, including scanning electron microscopy (sem), were performed.The fracture surface characteristics observed in those analyses were consistent with overload associated with bending stress.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Device examination showed a distal tip fracture, which was consistent with an overload associated with bending stress as per prior investigations involving the same device type and similar failure mode.However, a definitive root cause of the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that an instrument broke at the tip while in use.The broken portion did not contact the patient, and no fragments remained.The instrument had been used approximately 40 times, and the procedure experienced a brief delay of approximately five minutes while the instrument was replaced.The patient had no consequences or impact.Attempts have been made, and no further information has been provided.

• Brand Name: OXF CMNTLS IMPLANT INSERT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED,METAL/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25253368
• Report Number: 3002806535-2026-00197
• Device Sequence Number: 14826711
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(10)ZB160807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB160807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown