MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL 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	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, and h11.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).H3- customer has indicated that the product will not 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 the impactor tip fractured after impacting the femur.There is no additional information available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h6, and h11.Visual examination of the provided picture identified a femoral ps impactor pad.From the photo provided it is not possible to confirm the reported event.No product was returned therefore no further evaluation can be made.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint is not confirmed, unable to confirm the reported event from the photo provided.The device was discarded and therefore no product has been returned to enable further evaluation.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue.To monitor for trends.

• Brand Name: FEMORAL 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: 21420491
• Report Number: 0001822565-2025-00419
• Device Sequence Number: 20774334
• Product Code: JWH
• UDI-Device Identifier: 00889024232884
• UDI-Public: (01)00889024232884(10)64726686
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2025

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: 42509909300
• Device Lot Number: 64726686
• Was Device Available for Evaluation?: No
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 07/16/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/07/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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