MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PSN FEM PS IMPACTOR PAD; INSTRUMENT, KNEE

Catalog Number	42509909300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2- japan.H3- customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that an impactor pad fractured during femoral implant insertion.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2b, d9, g1, g3, g6, h1, h2, h3, h6, and h11 visual examination of the returned product identified signs of repeated use (dings and marring on the impactor surface).The device is fractured (unable to determine if all pieces are returned).The fracture surface was found to be consistent with the device fractures analyzed in zrm_wa_0507_19, which indicates overload failure or low cycle fatigue culminating in the overload failure.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event is attributed to wear and tear of the device from repeated use over time.This complaint is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental 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: PSN FEM PS IMPACTOR PAD
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22777182
• Report Number: 0001822565-2025-02868
• Device Sequence Number: 9449673
• Product Code: JWH
• UDI-Device Identifier: 00889024232884
• UDI-Public: (01)00889024232884(10)63870614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113369
• 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): 01/29/2026

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: 42509909300
• Device Lot Number: 63870614
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2018
• 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