BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++

    MDR report key: 17563389 · Received August 17, 2023

    Report

    Report Number
    1038671-2023-01979
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    November 10, 2010
    Report Date
    October 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862041326
    PMA / PMN Number
    K082022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. PENDING INVESTIGATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 1412863, 200-02-35 - THREE PEG PATELLA 35MM; 1895410, 200-02-35 - THREE PEG PATELLA 35MM; 1863163, 200-04-45 - CEMENTED FINNED TIB. TRA SZ 4F/5T; 1700843, 200-04-55 - CEMENTED FINNED TIB. TRA SZ 5F/5T; 1043619, 200-24-15 - CR TIBIAL INSERT SZ4, 15MM; 1842783, 200-75-09 - CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++; 1842792, 200-75-09 - CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++; 1862367, 230-02-05 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5; 1865549, 230-03-04 - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 4. CONCLUSIONS: MANUFACTURER NARRATIVE UPDATED: THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. ADDITIONALLY, THE DEVICES WERE IMPLANTED FOR OVER TEN YEARS PRIOR TO THE REPORTED FAILURE. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND NO IMAGES, RADIOGRAPHS, OR RELEVANT CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2010. THE DEVICE IS NOT EXPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. 3044, AND PENDING IN THE EASTERN DISTRICT OF NEW YORK. PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT, WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963052 CR TIBIAL INSERT SZ 5, 9MM, SLOPE ++ SEE H10 JWH EXACTECH, INC. 10885862041326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention