BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ3, 15MM

    MDR report key: 17539586 · Received August 14, 2023

    Report

    Report Number
    1038671-2023-01933
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    September 20, 2022
    Report Date
    January 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040275
    PMA / PMN Number
    K932776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2143691, 02-012-45-3040 - LGC TIBIAL FIT TRAY CEM SZ 3F / 4T. 2223162, 200-02-32 - THREE PEG PATELLA 32MM. 1961297, 230-03-03 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0019-2022 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0019-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. D10: CONCOMITANTS: (B)(6) 02-012-45-3040 - LGC TIBIAL FIT TRAY CEM SZ 3F / 4T. (B)(6) 200-02-32 - THREE PEG PATELLA 32MM. (B)(6) 230-03-03 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 3. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR 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 USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS 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

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2012. APPROXIMATELY 10 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: FAILED RIGHT KNEE. THERE WAS A LARGE NON BLOODY EFFUSION AND EXTENSIVE SYNOVITIS THROUGHOUT THE ENTIRE KNEE. THERE WAS GROSS POLYETHYLENE WEAR ON THE TIBIAL INSERT AND FLAKES OF POLYETHYLENE SCATTERED THROUGHOUT THE KNEE. PATELLAR COMPONENT WAS IN GOOD CONDITION WITH NO SUBSTANTIAL WEAR. THE FEMORAL AND TIBIAL COMPONENTS WERE EACH REMOVED WITH MINIMAL IATROGENIC BONE LOSS. ON THE FEMORAL SIDE THERE WAS SUBSTANTIAL OSTEOLYSIS WITH NEAR COMPLETE LOSS OF BOTH POSTERIOR CONDYLES AND EXTENSIVE ANTERIOR BONE LOSS UNDER THE FEMORAL FLANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085096 CR TIBIAL INSERT SZ3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. CR TIBIAL INSERT SZ3, 15MM UNK 10885862040275

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R SEE H10| SEE H11.