MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 12MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during knee arthroplasty that the articular surface could not be seated in the proper position on the tibial tray.As a result, another articular surface was used to complete the procedure.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona stemmed cemented tibial component right size d catalog #: 42532006702 lot #: 66570539 g2 - report source - foreign: the event occurred in japan the complainant 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.Visual evaluation of the returned articular surface confirmed that the dovetail feature was flared out and one side of the condyle was found to have a hole through it.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 available at the time of this report.

• Brand Name: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 12MM
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20678234
• Report Number: 3007963827-2024-00454
• Device Sequence Number: 15578230
• Product Code: MBH
• UDI-Device Identifier: 00889024468115
• UDI-Public: (01)00889024468115(17)251020(10)64919252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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 Expiration Date: 10/20/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522100412
• Device Lot Number: 64919252
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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: Unknown