BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 11.0 T1

    MDR report key: 14734021 · Received June 17, 2022

    Report

    Report Number
    0001825034-2022-01431
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    February 1, 2022
    Report Date
    June 17, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304514294
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110010246 ¿ G7 SHELL ¿ 64809428; 30103606 ¿ G7 LINER ¿ 65051580; 650-0662 ¿ BIOLOX HEAD ¿ 3033498. (B)(4). MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING. FWB WITH ANTALGIC GAIT, ROM: 0-90 DEGREES. HAVING SEVERE PAIN AND PROBLEMS WALKING. REVISION OF FEMORAL COMPONENT ONLY DUE TO STEM SUBSIDENCE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 3 MONTHS POST IMPLANTATION DUE TO PAIN AND DIFFICULTY WALKING. DURING THE PROCEDURE, THE FEMORAL COMPONENT WAS NOTED TO HAVE SUBSIDED. THE CUP AND LINER REMAINED IMPLANTED WHILE THE FEMORAL COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203284 TPRLC 133 MP TYPE1 PPS SO 11.0 T1 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6992251 00880304514294

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R