BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM

    MDR report key: 19131261 · Received April 18, 2024

    Report

    Report Number
    1038671-2024-00898
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    August 18, 2023
    Report Date
    November 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001771
    PMA / PMN Number
    K093360
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECALL NUMBER: Z-0021-2022. 1038671-2024-04517 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: CONCOMITANTS: 3804182 02-012-35-2509 - LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM. 3719174 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5. 3760551 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 3832510 200-02-32 - THREE PEG PATELLA 32MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-0021-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2024-04517. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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.

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 3804182 02-012-35-2509 - LOGIC TIBIA PS MOD INSRT SZ 2.5 9MM 3719174 02-010-01-0325 - LOGIC FEMORAL PS CEM RIGHT SZ 2.5 3760551 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T 3832510 200-02-32 - THREE PEG PATELLA 32MM. THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 8 YEARS AND 6 MONTHS AFTER INITIAL IMPLANT. OP REPORT - POSTOPERATIVE DIAGNOSIS ; FAILED RIGHT TOTAL KNEE POLYETHYLENE PREMATURE WEAR AND FAILED LOOSE FEMORAL COMPONENT DUE TO OSTEOLYSIS FROM POLY WEAR NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499043 LOGIC TIBIA PS MOD INSRT SZ 2.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001771

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Hospitalization| R SEE H10