MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF L 13MM 8-11/EF; PROSTHESIS, KNEE

Catalog Number	42512100813
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual evaluation could not be performed.The source of the debris cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history found no additional related issues for the reported part and part lot combinations.Medical records were not provided.The event is not confirmed.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This event was initially reported under a different manufacturer number in mdr: 0001822565-2025-01571.
Event or Problem Description
It was reported a hair was found inside the implant packaging.No patient harm or impact was reported.

• Brand Name: PERSONA MC VE ASF L 13MM 8-11/EF
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23292029
• Report Number: 3007963827-2025-00409
• Device Sequence Number: 4889483
• Product Code: MBH
• UDI-Device Identifier: 00889024469327
• UDI-Public: (01)00889024469327(17)290316(10)66561246
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 42512100813
• Device Lot Number: 66561246
• 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: 09/24/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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: Female
• Patient Weight: 63 KG