MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VAN PS OPEN INTL FEM-RT 62.5; PROSTHESIS, KNEE

Catalog Number	183106
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: poland.H6 - component code - proposed code is mechanical (g04) - femur.The complainant 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
It was reported during knee arthroplasty that when the sterile packaging was opened for the femoral component, the surface of the implant appeared to be covered in a foil-like material.The device was not used to complete the procedure.No adverse events were reported as a result of this malfunction.
Event or Problem Description
Upon review of the information, it was determined to be not reportable as this product sterility was not breached.The initial report should be voided.
Additional Manufacturer Narrative
Upon review of the information, it was determined to be not reportable as this product sterility was not breached.The initial report should be voided.

• Brand Name: VAN PS OPEN INTL FEM-RT 62.5
• Common Device Name: PROSTHESIS, 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: 23002923
• Report Number: 0001825034-2025-02835
• Device Sequence Number: 13011163
• Product Code: JWH
• UDI-Device Identifier: 00880304270787
• UDI-Public: (01)00880304270787(17)341007(10)66874396
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K171054
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 183106
• Device Lot Number: 66874396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/30/2025
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown