BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 11.0

    MDR report key: 7757159 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05799
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    November 12, 2013
    Report Date
    September 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: ITEM # 650-1057, HEAD, LOT # 715980. ITEM # 11-104054, SHELL, LOT # 241660. ITEM # EP-105994, LINER, LOT # 680580. ITEM # 650-1064, TAPER, LOT # 355880.

    Additional Manufacturer Narrative · 1

    UDI (B)(4). THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. REVIEW OF OPERATIVE NOTES CONFIRM THAT THE PATIENT UNDERWENT A REVISION OF THE LEFT HIP DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND PAIN. THE SURGEON NOTED THAT THERE WAS RADIOLUCENCY AND LOOSENING AROUND THE FEMORAL COMPONENT AND THE STEM COULD BE EASILY REMOVED WITH NO EVIDENCE OF GROWTH. A NEW STEM WAS PLACED AND POST-OPERATIVE IMAGES IDENTIFIED THAT ALL IMPLANTS WERE POSITIONED WELL. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 · 1

    IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. THE PATIENT HAD COMPLAINTS OF PAIN AND DISCOMFORT AND ASPIRATION RESULTED IN NEGATIVE CULTURES. RADIOLUCENCIES WERE NOTED ABOUT THE FEMORAL COMPONENT, LEADING TO SUSPICION OF LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599894 TPRLC 133 MP TYPE1 PPS HO 11.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2685482

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R