MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 FEMORAL IMPACTOR; ORTHOPAEDIC IMPLANT IMPACTOR

Catalog Number	32-420127
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during surgery, the edges of the oxford pe attachment/femoral insert detached when impacting the oxf-micro-anti-impingement guide and fell into the surgical site.Photos show signs of wear and a fracture issue.The surgeon was able to complete the procedure using an alternative device, and the broken component did not come into contact with the patient.No fragments were retained.The instrument had been used twice prior to this event.There was no impact on the patient and no delay in the procedure.Attempts have been made, and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in europe: germany.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h4, h11.The product returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, e2, e3, g3, g6, h2, h3, h6, h11.Complaint can be confirmed through the returned product analysis.The product involved in the reported event was returned for investigation.Technical evaluation showed signs of repeated use, including nicks/gouges on the oxford femoral impaction head.Damage was also observed on the handle end, consistent with strike marks.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 could not be determined.However, the instrument has likely become deformed and damaged due to wear and tear from repeated use over time in the field.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: OXF UNI PH3 FEMORAL IMPACTOR
• Common Device Name: ORTHOPAEDIC IMPLANT IMPACTOR
• 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: 23766344
• Report Number: 3002806535-2025-00584
• Device Sequence Number: 10615774
• Product Code: HWA
• UDI-Device Identifier: 05019279477333
• UDI-Public: (01)05019279477333(10)ZB7902046
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 05/05/2026

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: 32-420127
• Device Lot Number: ZB7902046
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 05/01/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/12/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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
• Patient Sex: Unknown