BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 7746786 · Received August 3, 2018

    Report

    Report Number
    0001825034-2018-05397
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    May 12, 2017
    Report Date
    September 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK062994
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INFORMATION PROVIDED IN THIS SUPPLEMENTAL REPORT DOES NOT CHANGE THE PREVIOUS INVESTIGATION ALREADY SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 163667, MOD HEAD NECK, LOT # UNKNOWN; CATALOG #: 11-104152, 3 HOLE SHELL, LOT # UNKNOWN. 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 PATIENT RECEIVED A BURSAL INJECTION APPROXIMATELY 6.5 YEARS POST INITIAL LEFT TOTAL HIP ARTHROPLASTY. 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
    590437 TAPERLOC FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R