MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PSN PK TIBIA IMPACTOR; INSTRUMENT, KNEE

Catalog Number	42539909000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while impacting the trial tibial baseplate into the tibia, the ppk tibial impactor on the thin end snapped off.The broken piece was able to be retrieved from the patient.There was no consequences or impact to the patient.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in new zealand.H6: component code: mechanical (g04) - impactor.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.
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; d9; g3; g6; h1; h2; h3; h4; h6; h11.Complaint can be confirmed through the returned product analysis.Visual examination of the returned product identified signs of repeated use (surface marring, strike marks on the strike plate, and indents, dings, nicks and scratches on the impactor pad).Device is fractured into two pieces.The device history record was reviewed and no discrepancies relevant to the reported event were found.Device has a potential field age of 7 years and exhibits signs of repeated use.The root cause of the reported event is attributed to wear and tear of the device from repeated use over time.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.

• Brand Name: PERSONA PSN PK TIBIA IMPACTOR
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22673560
• Report Number: 0001825034-2025-02315
• Device Sequence Number: 14409088
• Product Code: HWA
• UDI-Device Identifier: 00880304810235
• UDI-Public: (01)00880304810235(10)64034374
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 42539909000
• Device Lot Number: 64034374
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2018
• 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