BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    MDR report key: 6471985 · Received April 7, 2017

    Report

    Report Number
    3006946279-2017-00060
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    February 23, 2017
    Report Date
    June 22, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). PMA/510(K) NUMBER - THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) K911684. 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: 3002806535-2017-00207.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. ANALYSIS OF X-RAYS PROVIDED IN INITIAL SURGICAL REPORT SHOWED A GOOD POSITIONING OF THE FEMORAL AND ACETABULAR COMPONENTS. ANALYSIS OF REVISION PROCEDURE X-RAY SHOWS A DISLOCATION BETWEEN THE BIPOLAR COMPONENT AND THE FEMORAL HEAD. DIMENSIONAL ANALYSIS OF THE RETURNED FEMORAL HEAD FOUND PRODUCT IS CONFORMED TO THE DEVICE SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED PATIENT EXPERIENCED LEFT HIP DISLOCATION ONE DAY POST-IMPLANTATION. THE PATIENT WAS REVISED TWO DAYS POST-IMPLANTATION DUE TO LUXATION AND DISASSEMBLY OF COMPONENTS. 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
    255182 BIOMET COBALT-CHROME FEMORAL COMPONENTS PROSTHESIS, HIP JDI BIOMET FRANCE S.A.R.L. N/A 00J3097082

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R FEMORAL STEM PN 650-0337 LN 3962127