MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD MP SLOT POST CUT GD SML; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	32-422980
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in china.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 the patient underwent reoperation for debridement and exploration one week post initial surgery due to a metal radiolucent shadow revealed on an x-ray performed four days post implantation.During the procedure, the object was identified as the metal pin from the femoral posterior condyle osteotomy instrument within a unicondylar arthroplasty kit, and it was retrieved.No further consequences or impact to the patient were reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product involved in the reported event was returned for investigation.A visual inspection of the returned instrument found it to exhibit signs of repeated use with the cut slot showing wear/blade marks.The cut guide was missing both the 2.5 dia.Pin (item # 37-100025-4) and the red pomalux plug (item # 32-420325-4) neither subcomponent was returned.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided and reviewed by a radiologist.The review identified intraoperative fluoroscopic images of the knee show changes of noncompartmental arthroplasty.Some of the images show an oval metallic density projecting over the lateral compartment near the intercondylar notch, which could correspond to a retained foreign body as suggested in the given history.A definitive root cause could not be determined.The most likely cause is inadequate fixation of the pin.Assembly requirements in the design drawing have been updated to address this issue.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 MP SLOT POST CUT GD SML
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• 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: 23755660
• Report Number: 3002806535-2025-00568
• Device Sequence Number: 20309361
• Product Code: LXH
• UDI-Device Identifier: 05019279440016
• UDI-Public: (01)05019279440016(10)ZB140901
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 32-422980
• Device Lot Number: ZB140901
• 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: 11/16/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2014
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown