MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CMNTLS IMPLANT INSERT; KNEE INSTRUMENT

Catalog Number	32-422097
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: the primary unique device identification (udi) number is not applicable as the device's product lot number is unknown.G2 ¿ foreign ¿ canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during surgery, the front clamp foot of the oxford cementless inserter broke.Another oxford inserter was used to complete the case.The instrument was reported to have been used more than 100 times.No harm to patient and no delay to surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report. .
Additional Manufacturer Narrative
(b)(4).D4: the primary unique device identification (udi) number is not applicable as the device's product lot number is unknown.Attempts have been made to gather all product identification information, and no further information has been provided.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h11.No product was returned for evaluation, however, the image provided shows that a part at the front section (tip) of the instrument has broken off.Apart from the fracture, the instrument shows significant signs of wear.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item.However, due to the lack of the lot number, an additional lot search could not be performed.A definitive root cause 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d4, d9, g3, g6, h2, h3, h4, h11.Corrected: e1, h6.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.The following section was corrected h6 - component code complaint can be confirmed through the returned product analysis.The product involved in the reported event was returned for investigation.The returned cementless implant inserter, was found to exhibit evidence of repeated use, including nicks and gouges along the instrument body.The distal tip (hook) is fractured.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.A definitive root cause cannot 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
No further event information available at the time of this report.

• Brand Name: OXFORD CMNTLS IMPLANT INSERT
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22642558
• Report Number: 3002806535-2025-00291
• Device Sequence Number: 12925224
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)111021(10)ZB100401
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/06/2026

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: ZB100401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 09/19/2025; 03/06/2026
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/20/2025; 10/15/2025; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2011
• 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