MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF R 10MM 8-11/GH; PROSTHESIS, KNEE

Catalog Number	42522100910
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bearing would not fit on the tibial implant.A second bearing was used to complete the procedure.No patient harm or impact was reported.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h6.Inspection of the bearing was performed confirming product identifiers, engraved reference number, the cut-out matches the print and the device is a right.Articular surfaces.Visual examination of the returned articular surface identified minor surface scratches and dull wear marks.The dovetail features were found to be flared on both sides with additional wear around the non articular surface (extractor slot).Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Review of the complaint history identified similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is confirmed.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PERSONA MC VE ASF R 10MM 8-11/GH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23280451
• Report Number: 3007963827-2025-00404
• Device Sequence Number: 8956135
• Product Code: MBH
• UDI-Device Identifier: 00889024468498
• UDI-Public: (01)00889024468498(17)300430(10)67271965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 42522100910
• Device Lot Number: 67271965
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Male