MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS; PROSTHESIS, KNEE

Catalog Number	42502805401
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that prior to an initial total knee arthroplasty, the femoral implant was found to have holes present on the inner poly bag and residue was present on surface of the device.The device was not used during the procedure due to concern over sterility.There was no patient impact and no adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual evaluation of the provided photos identified white debris on the device that is visually consistent with foam debris from the foam insert.The poly bag was torn allowing the friction between the device and the foam insert.Device history record was reviewed and no discrepancies related to the reported event were found.Investigation results concluded that the reported event can be attributed to transit damage.The condition of the device when it left zimmer biomet control is considered conforming to specification.Reported event was confirmed by review of provided photographs.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PERSONA FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS
• Common Device Name: PROSTHESIS, 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: 21159738
• Report Number: 0001822565-2025-00135
• Device Sequence Number: 8594600
• Product Code: MBH
• UDI-Device Identifier: 00889024470170
• UDI-Public: (01)00889024470170(17)291031(10)64488378
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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
• Report Date (Section B): 05/01/2025

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: 42502805401
• Device Lot Number: 64488378
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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