MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA CEMENTED ALL POLY PATELLA 29MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision of the articular surface and patellar components approximately two (2) years post-operatively due to unknown reasons.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona medial congruent articular surface right 10mm catalog #: 42522100810, lot #: 65560779, persona cruciate retaining standard porous femoral component catalog #: 42502806802, lot #: 65098217, persona two-peg porous trabecular metal tibial tray right size f catalog #: 42530007502, lot #: 65569857.G2 - report source - foreign: event occurred in australia.The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision of the articular surface and patellar components approximately two (2) years post-operatively due to loosening.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b4, b5, g3, g6, h2, h6, h11.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent a right knee arthroplasty revision approximately two (2) years post-operatively due to patellar loosening and pain.Attempts have been made, however, no additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.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.

• Brand Name: PERSONA CEMENTED ALL POLY PATELLA 29MM
• 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 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: 21706689
• Report Number: 0002648920-2025-00080
• Device Sequence Number: 10010607
• Product Code: MBH
• UDI-Device Identifier: 00889024247680
• UDI-Public: (01)00889024247680(17)270812(10)65550973
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 65550973
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 04/30/2025; 06/03/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/23/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male