BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP/MAGNUM ACETABULAR SHELL 48 X 42MM POROUS COATED

    MDR report key: 6407820 · Received March 15, 2017

    Report

    Report Number
    3002806535-2017-00139
    Event Type
    Injury
    Date Received
    March 15, 2017
    Date of Event
    November 29, 2013
    Report Date
    March 2, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS- MEDICAL PRODUCTS - BI-METRIC FEMORAL STEM CATALOG#: 162312, LOT#: 1466537, MAGNUM FEMORAL HEAD CATALOG#: 157442, LOT#: 1475106, MAGNUM TAPER ADAPTER CATALOG#: 139260, LOT#: NI. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00138, 3002806535-2017-00139.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO ELEVATED METAL ION LEVELS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190238 RECAP/MAGNUM ACETABULAR SHELL 48 X 42MM POROUS COATED PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 1413359

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R