BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM EXTENSION W/SLOT 120L X18 MM

    MDR report key: 13905169 · Received March 25, 2022

    Report

    Report Number
    1038671-2022-00280
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    March 2, 2022
    Report Date
    September 22, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862049025
    PMA / PMN Number
    K012251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: FEMUR AND POLY. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: AS REPORTED, THIS 52 Y/O OBESE MALE PATIENT HAD A REVISION TKA. SURGEON KEPT TIBIAL IMPLANTS AND REVISED TO CCK TRULIANT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION PROVIDED AFTER MULTIPLE ATTEMPTS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, THIS (B)(6) MALE PATIENT HAD A REVISION TKA. SURGEON KEPT TIBIAL IMPLANTS AND REVISED TO CCK TRULIANT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053704 STEM EXTENSION W/SLOT 120L X18 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. STEM EXTENSION W/SLOT 120L X18 MM UNK 10885862049025

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention