BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS TIBIAL INSERTS SZ 4, 9MM

    MDR report key: 16742283 · Received April 14, 2023

    Report

    Report Number
    1038671-2023-00693
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    October 12, 2022
    Report Date
    December 31, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862048387
    PMA / PMN Number
    K933610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, PATELLAR LOOSENING, AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THESE DEVICES APPEAR TO HAVE BEEN IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED EVENT. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND PRODUCT INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE - (B)(6). IT WAS REPORTED BY THE LEGAL DEPARTMENT THE PATIENT HAD BILATERAL KNEE REPLACEMENT ON (B)(6) 2006. THE PATIENT HAD A LEFT KNEE REVISION (B)(6) 2022, APPROXIMATELY 16 YEARS AND 4 MONTHS AFTER INITIAL REPLACEMENT. LEFT KNEE WAS REVISED DUE TO OSTEOLYSIS DUE TO POLYETHYLENE WEAR STATUS POST RECALLED EXACTECH TOTAL KNEE REPLACEMENT, ASEPTIC LOOSENING. PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. SERIAL #: (B)(4), CATEGORY #: 204-24-09 - PS TIBIAL INSERTS SZ 4, 9MM, SERIAL NUMBER (B)(4) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K933610. RECALL: Z-0021-2022. NO EBI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143706 PS TIBIAL INSERTS SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM UNK 10885862048387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention