MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA FIXED CEMENTED RIGHT SIZE E; PROSTHESIS, KNEE

Catalog Number	42542007102
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery of the tibial component for an unknown reason.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial stem extension: catalog#: ni, lot#: ni; unknown articular surface: catalog#: ni, lot#: ni; unknown femoral component: catalog#: ni, lot#: ni.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 right total knee arthroplasty.Subsequently, one (1) year and six (6) months post-implantation, the patient began to experience pain and stiffness.Imaging showed subsidence of the tibial component and a revision surgery was performed to replace the affected components.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h10; h11.Visual examination of the provided pictures identified the explanted tibia, tibial stem, and articular surface with bio-debris on the devices.Extensive bio-debris was noted around the base of the tibial plate.No further evaluation can be made from the provided pictures.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: abnormal radiolucency along the proximal tibial implant concerning for tibial implant loosening.Root cause was unable to be determined.Reported event was unable to be confirmed.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 at time of this report.

• Brand Name: PERSONA TIBIA FIXED CEMENTED RIGHT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19168785
• Report Number: 0001822565-2024-01384
• Device Sequence Number: 7938640
• Product Code: JWH
• UDI-Device Identifier: 00889024562882
• UDI-Public: (01)00889024562882(17)310420(10)65000268
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2024

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 Catalogue Number: 42542007102
• Device Lot Number: 65000268
• 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: 03/31/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 08/14/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/19/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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 Age: 74 YR
• Patient Sex: Male