MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ART. SURFACE FIXED BEARING (CPS) RIGHT 14 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D11 medical devices: unknown femoral, catalog #: ni, lot #: ni.Unknown tibial tray, catalog #: ni, lot #: ni.G2 foreign source: australia.Customer has indicated that the product will not 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 patient underwent a right knee arthroplasty.Subsequently, patient was revised due to instability.The tibial insert was removed and replaced with a thicker poly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, d6, d10, g3, g6, h2, and h11.D6a implant date: unknown date in july 2020 d10 medical devices: femur cemented posterior stabilized (ps) standard right size 6 catalog#: 42500606002 lot#: 64472972 tibia cemented 5 degree stemmed right size c catalog#: 42532006402 lot#: 64520929 stem extension tapered cemented 14 mm diameter +30 mm length catalog#: 42557000114 lot#: 64601068 all-poly patella cemented 29 mm diameter catalog#: 42540200029 lot#: 64545070.
Event or Problem Description
It was reported that patient underwent a right knee revision approximately four years post-implantation due to instability.The tibial insert was removed and replaced with a thicker poly.
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 information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: assessed 2 images taken in june 2024, and patient was revised in (b)(6) 2024 due to instability and needed a thicker art surface, all other components remained.As all other components remained, implying well fixed, aligned, stable components, images will not be submitted to mmi to review.Advanced imaging would be required to assess poly and instability issues.A definitive root cause cannot be determined.This complaint cannot 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.

• Brand Name: PERSONA ART. SURFACE FIXED BEARING (CPS) RIGHT 14 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: 20127884
• Report Number: 3007963827-2024-00333
• Device Sequence Number: 7483152
• Product Code: MBH
• UDI-Device Identifier: 00889024244467
• UDI-Public: (01)00889024244467(17)241130(10)64599819
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 12/12/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522600514
• Device Lot Number: 64599819
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 12/03/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/14/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown