BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 19757624 · Received July 16, 2024

    Report

    Report Number
    1038671-2024-02410
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    February 21, 2024
    Report Date
    October 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314581
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-022-44-5011 - TRULIANT TIB IMP PSC INSERT SZ 5, 11MM 5758926. 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T 5820426. 200-02-38 - THREE PEG PATELLA 38MM 5626403. 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE 5788849. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 6120128. 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK 6122086.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE KNEE REVISION REPORTED IS MOST LIKELY THE RESULT OF FEMORAL LOOSENING AND SUBSEQUENT THIRD BODY WEAR ON THE TIBIAL INSERT. THE CHANGED KINEMATICS FOLLOWING THE REPORTED HIP FUSION ARE LIKELY CONTRIBUTING FACTORS TO THE SEQUENCE OF EVENTS BUT CANNOT BE CONFIRMED FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: (B)(6), 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T; (B)(6), 200-02-38 - THREE PEG PATELLA 38MM; (B)(6), 201-78-82 - COLLAR FIXATION PIN 2PK 40MM, QUICK RELEASE; (B)(6), 201-78-89 - 3" DRILL BIT, MOD. HEX 2 PACK. THE REASON FOR THE KNEE REVISION REPORTED IS MOST LIKELY THE RESULT OF FEMORAL LOOSENING AND SUBSEQUENT THIRD BODY WEAR ON THE TIBIAL INSERT. THE CHANGED KINEMATICS FOLLOWING THE REPORTED HIP FUSION ARE LIKELY CONTRIBUTING FACTORS TO THE SEQUENCE OF EVENTS BUT CANNOT BE CONFIRMED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, SALES REP REACHED OUT TO MANUFACTURE ENGINEER TO INFORMED THAT SURGEON DID A REVISION OF A FEMORAL COMPONENT AND TIBIAL INSERT. ALSO ACCORDING TO SALES REP VERY SOON AFTER THE KNEE REPLACEMENT THE PATIENT UNDERWENT A SAME SIDE HIP FUSION WHERE THE HIP WAS FUSED WITH INTERNAL ROTATION. THE SURGEON BELIEVE THIS MAY HAVE LED TO COMPLICATIONS IN THE KNEE JOINT. SALES REP IS SENDING THE TIBIAL INSERT BACK AND PER DOCTOR¿S REQUEST FOR DEVICE ANALYSIS REVIEW. THE ORIGINAL DATE OF SURGERY ACCORDING TO SALES REP WAS (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694755 EXACTECH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862314581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention