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

Catalog Number	32-420127
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Attempts have been made to gather all product identification information, and no further information has been provided.G2- 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 the during surgery, the impactor head cracked upon impaction.There was no impact to the patient, no foreign body retained, and no surgical delay.Attempts have been made, and all additional information received has been included in 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, d4, d9, g3, g6, h2, h11.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a 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, d2a, d4, g3, g6, h2, h3, h4, h6, h11.The product involved in the reported event was returned for investigation.Visual evaluation showed that the product exhibited signs of repeated use, including dings, dents, and scratches on the strike plate.The impactor pad also displayed dings, dents, scratches, and gouges.Fracture of the pad was confirmed, and a portion of the fractured material appears to be missing.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 no additional similar complaints for the reported 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 is available at the time of this report.

• Brand Name: OXF UNI PH3 FEMORAL IMPACTOR
• Common Device Name: 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: 23448273
• Report Number: 3002806535-2025-00523
• Device Sequence Number: 12990925
• Product Code: HWA
• UDI-Device Identifier: 05019279477333
• UDI-Public: (01)05019279477333(10)ZB170101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/25/2026

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: ZB170101
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 03/25/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/18/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2017
• 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