BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4, 12MM

    MDR report key: 18229146 · Received November 29, 2023

    Report

    Report Number
    1038671-2023-02876
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    May 27, 2020
    Report Date
    October 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312655
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5991387 02-012-50-4011 - TRU TIB AUG 1/2 SIZE 4, 5MM 6060604 02-012-60-1425 - TRU STEM EXT 14MM X 25MM 6199803 02-020-13-0340 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4 5639708 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T 5665478 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 5799025 204-70-00 - TIBIAL STEM EXT. SCREW PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REPORTED EVENT CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO PROSTHESIS WEAR AND/OR 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, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2020. THIS DEVICE HAS NOT BEEN EXPLANTED. 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. 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
    920517 TRULIANT TIB IMP CRC INSERT SZ 4, 12MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862312655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10