BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP/MAGNUM ACETABULAR SHELL

    MDR report key: 6829799 · Received August 30, 2017

    Report

    Report Number
    3002806535-2017-00866
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    April 6, 2017
    Report Date
    May 17, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE - UNKNOWN DATE IN (B)(6) 2017. (B)(4). EXPLANT DATE - UNKNOWN DATE IN (B)(6) 2017. CONCOMITANT PRODUCT: P/N 157856 RECAP SHELL COCR PC DIA56/50MM L/N 1676441, P/N 162312 BI-METRIC PC 11X135MM T1 L/N 1525032, P/N 139256 M2A-MAGNUM 42-50 TPR INSRT STD L/N 1676752, P/N 157450 M2A-MAGNUM MOD HD SZ 50MM L/N 848420. THE DEVICE WAS NOT RETURNED BY THE PATIENT ATTORNEY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, AND METAL ON METAL HIP DISEASE. DURING THE REVISION, A SMALL AMOUNT OF RED FLUID AROUND THE GREATER TROCHANTER, TRUNNION CORROSION, AND VERY SOFT NECROTIC TISSUE IN THE GREATER TROCHANTER WERE NOTED. THE METAL ON METAL COMPONENTS WERE REVISED TO POLY ON CERAMIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT HIP REVISION DUE TO ADVERSE REACTION TO METAL DEBRIS. FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611242 RECAP/MAGNUM ACETABULAR SHELL PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1676441

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R