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

Catalog Number	42589000701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information, and no further information has been provided.H3- customer has not indicated whether 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 while impacting implant.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, d4, d9, g1, g3, g6, h1, h2, h4, and h11.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PSN REV FEM IMPT 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: 24443548
• Report Number: 0001822565-2026-00609
• Device Sequence Number: 10301026
• Product Code: JWH
• UDI-Device Identifier: 00889024559400
• UDI-Public: (01)00889024559400(10)64758882
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2026

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: 42589000701
• Device Lot Number: 64758882
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 06/04/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/24/2026; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2020
• 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