BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 6 9MM

    MDR report key: 17906056 · Received October 10, 2023

    Report

    Report Number
    1038671-2023-02496
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    April 7, 2022
    Report Date
    October 10, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304704
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    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. D10. CONCOMITANTS: 02-012-60-1425 - TRU STEM EXT 14MM X 25MM 6668184. 02-020-11-0360 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 6 6560083. 02-022-45-6050 - TRULIANT TIB FIT TRAY CEM SZ 6F / 5T 6657892. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 6814396. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5085294. 204-70-00 - TIBIAL STEM EXT. SCREW 6970548. H3. INVESTIGATION RESULTS-THE TRULIANT TIB IMP PS INSERT SZ 6 9MM, SN: (B)(6), IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION, THE PATIENT INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION. CLINICAL FACTORS FOR THE REVISION- ARTHROFIBROSIS WITH SIGNIFICANT FLEXION CONTRACTURE AND CHRONIC QUADRICEPS TENDON RUPTURE. THE PATIENT HAD A POST OPERATIVE FALL THAT CAUSED A PATELLAR FRACTURE AND THEN THE IMPROPER WEARING OF A BRACE THAT MOST LIKELY LED TO LIMB CONTRACTURE. THERE IS NO INDICATION THAT THE DEVICES WERE THE CAUSE OF THE FALL, FLEXION CONTRACTURE, OR CHRONIC QUADRICEPS TENDON RUPTURE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2021. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. ON (B)(6) 2022, REVISION OPERATIVE REPORT- POSTOPERATIVE DIAGNOSIS: 1. FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO ARTHROFIBROSIS WITH SIGNIFICANT FLEXION CONTRACTURE. 2. CHRONIC QUADRICEPS TENDON RUPTURE. INDICATIONS: 66 YO MALE HAD RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. HE HAD A FALL POSTOPERATIVELY ON (B)(6) 2021, SUSTAINING A RIGHT PATELLAR FRACTURE WITH DISRUPTION OF HIS QUADRICEPS TENDON. HE UNDERWENT QUADRICEPS TENDON REPAIR AND ORIF OF THE RIGHT PATELLA ON (B)(6) 2021. HE WAS INSTRUCTED TO REMAIN IN A KNEE BRACE LOCKED IN EXTENSION; HOWEVER, THE BRACE SLID DOWN HIS LEG AND BENT THE KNEE WELL PAST 90 DEGREES. HE ULTIMATELY FAILED THE FRACTURE FIXATION AS WELL AS THE QUADRICEPS REPAIR. HE CONTINUED TO HAVE A VERY LIMITED MOBILITY AND SPENT MOST TIME SITTING. HE SUBSEQUENTLY DEVELOPED A SIGNIFICANT FLEXION CONTRACTURE OF HIS RIGHT KNEE WITH THE INABILITY TO AMBULATE OR STAND, GIVEN EXTENSOR MECHANISM DISRUPTION. INFECTION WORKUP WAS NEGATIVE. PROCEDURE: THE COMPONENTS WERE WELL FIXED AND IN GOOD POSITION. A FULL REVISION WAS DONE TO IMPROVE FULL EXTENSION. THE PATIENT HAD A LARGE FRAGMENT OF THE SUPEROLATERAL PATELLA, WHICH HAD A REMAINING SCREW THAT WAS SLIGHTLY BENT [THE SCREW MENTIONED IS MOST LIKELY FROM THE ORIF]. ON INSPECTION OF THE POLYETHYLENE, THERE WAS NO OBVIOUS WEAR OR DELAMINATION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347060 TRULIANT TIB IMP PS INSERT SZ 6 9MM SEE H10 JWH EXACTECH, INC. 10885862304704

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H10.