MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PATELLA CEMENTED 38 MM DIAMETER; PROSTHESIS, KNEE

Catalog Number	42540000038
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an initial total knee arthroplasty, the packaging of the patella implant was found to be opened.There was no patient involvement and no adverse events have been reported as a result of the malfunction.A second device was used to complete the procedure without complication.
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.Visual evaluation of the provided photos/returned product found the product was previously opened.The product was part of a loaner kit and was not properly inspected prior to sending to the next customer.The product was delivered unsterile.Device history record was reviewed and no discrepancies related to the reported event were found.The condition of the device when it left zimmer biomet is considered non-conforming to specification.Investigation results concluded that the reported event is attributed to the operator not following the work instructions provided.Reported event was confirmed by evaluation of product and 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.

• Brand Name: PERSONA ALL POLY PATELLA CEMENTED 38 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21309439
• Report Number: 0002648920-2025-00035
• Device Sequence Number: 8076110
• Product Code: JWH
• UDI-Device Identifier: 00889024643727
• UDI-Public: (01)00889024643727(17)271205(10)65656741
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: 42540000038
• Device Lot Number: 65656741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• 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: 01/24/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: Prefer Not To Disclose