BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI METRIC/XR LAT RPP C/L 8MM

    MDR report key: 6609431 · Received June 2, 2017

    Report

    Report Number
    0001825034-2017-03541
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    February 18, 2015
    Report Date
    October 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK052089
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS - M2A-MAGNUM PF CUP 46ODX40ID/ PN US157846/ LN 342330, SELEX/MAGNUM MOD HD 40MM -3/ PN S031140/ LN 218320. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS, AS ITS LOCATION IS UNKNOWN. 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: 0001825034-2016-03027-1, 0001825034-2017-03540.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY FIVE YEARS POST IMPLANTATION DUE TO INSTABILITY, OSTEOLYSIS, PSEUDOTUMOR, METAL ON METAL ALLERGIC TYPE RESPONSE, AND SYNOVITIS. OPERATIVE NOTES INDICATE THAT THE PATIENT HAD NO GLUTEUS MINIMUS AND CAPSULE, AND WAS BASICALLY DIRECT TO THE HIP JOINT. THERE WAS ALSO SEVERE SOFT TISSUE LYTIC AREAS AS WELL AS A MASSIVE PSEUDOTUMOR OVER THE GREATER TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389284 BI METRIC/XR LAT RPP C/L 8MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 057290

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R