MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PAT VE 26 MM DIA; PROSTHESIS, KNEE

Catalog Number	42540200026
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while preparing implants for use in the operating theatre, significant deformation was observed in both the inner and outer device packaging.The device was not used and a secondary implant was retrieved to complete the procedure as it was not possible to confirm whether sterility remained intact.There was no patient impact and no adverse events have been reported as a result of the malfunction.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in singapore.The customer 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.

• Brand Name: PERSONA ALL POLY PAT VE 26 MM DIA
• 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: 23765385
• Report Number: 0002648920-2025-00340
• Device Sequence Number: 10615277
• Product Code: MBH
• UDI-Device Identifier: 00889024247673
• UDI-Public: (01)00889024247673(17)300316(10)67182436
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 42540200026
• Device Lot Number: 67182436
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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