BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5

    MDR report key: 18276520 · Received December 6, 2023

    Report

    Report Number
    1038671-2023-02911
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    March 27, 2023
    Report Date
    February 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314550
    PMA / PMN Number
    K170240
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K152170. (B)(6), 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. (B)(6), 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT. (B)(6), 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T. (B)(6), 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T. (B)(6), 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5. (B)(6), 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    1038671-2025-01081. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2025-01081. 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 FEMORAL LOOSENING AND PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. BOTH THE FEMORAL LOOSENING AND PROSTHESIS WEAR COULD NOT BE CONFIRMED PER EXAMINATION OF IMAGES AND RADIOGRAPHS OF THE EXPLANTED DEVICES AND COULD NOT BE FURTHER ASSESSED AS THE DEVICES WERE NOT PROVIDED FOR FURTHER EVALUATION. 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)2019. APPROXIMATELY 4 YEARS AND 3 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877194 TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862314550

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention SEE H10.| SEE H11.