BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM

    MDR report key: 15742757 · Received November 7, 2022

    Report

    Report Number
    1038671-2022-01414
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 17, 2022
    Report Date
    July 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862312679
    PMA / PMN Number
    K171045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION: CONCOMITANT DEVICE(S): 5532628 02-020-13-0245 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4.5; 5605581 02-022-45-4535 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/3.5T; 5665381 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT; 5972610 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; S013682 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK; S020030 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK; S020045 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK; S019042 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK; 4043019220 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE REPORTED PROSTHESIS WEAR AND SYNOVITIS, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE PHOTOGRAPHED INSERT DOES NOT APPEAR TO SHOW SIGNS OF WEAR THAT ARE INCONSISTENT WITH BEING IMPLANTED FOR APPROXIMATELY 3.25 YEARS. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 734, BEARINGS

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G REPORTING CONTACT AND REPORTING CONTACT E-MAIL, H6 CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE REPORTED PROSTHESIS WEAR AND SYNOVITIS, AS STATED IN THE EXPERIENCE REPORT. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE PHOTOGRAPHED INSERT DOES NOT APPEAR TO SHOW SIGNS OF WEAR THAT ARE INCONSISTENT WITH BEING IMPLANTED FOR APPROXIMATELY 3.25 YEARS. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL 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, APPROXIMATELY 3 YEARS POST OP THE INITIAL TSA, THIS MALE PATIENT WAS REVISED DUE TO WEAR ON POLY AND SYNOVITIS. PATIENT WAS COMPLAINING OF PAIN. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS UNAVAILABLE. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212300 TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-51-4510 UNK 10885862312679

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10.