MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CR RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522000411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni.G2: foreign: australia.The product will not be returned to zimmer biomet for investigation, as the product has been discarded as biohazard.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately two years post-implantation, the patient began to experience instability and was unhappy with the implanted prosthesis.Subsequently, the patient underwent revision surgery of the articular surface to address the instability.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual examination of the provided pictures identified bio-debris to the surface, however no damage was noted from the provided pictures.No further evaluation can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 ARTICULAR SURFACE FIXED BEARING CR RIGHT 11 MM HEIGHT
• 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: 20189974
• Report Number: 3007963827-2024-00345
• Device Sequence Number: 18165646
• Product Code: MBH
• UDI-Device Identifier: 00889024241565
• UDI-Public: (01)00889024241565(17)230831(10)64125829
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 42522000411
• Device Lot Number: 64125829
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 87 KG