BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-T M/H RAD SLD/APX SHL 50MM

    MDR report key: 6889230 · Received September 24, 2017

    Report

    Report Number
    0001825034-2017-07325
    Event Type
    Injury
    Date Received
    September 24, 2017
    Date of Event
    February 18, 2016
    Report Date
    September 23, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK993438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). CONCOMITANT PRODUCT(S):¿ A 11-163660 28MM M2A MOD HEAD -6MM NK LOT 388080; 15-105000 M2A TAPER 37/28MM LINER LOT 763680; 11-104107 MLRY-HD POR FMRL 7X140MM LOT 413410; 15-104050 M2A-T M/H RAD SLD/APX SHL 50MM LOT 241490. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02754, 0001825034-2017-02755, 0001825034-2017-07325. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. PATIENT UNDERWENT THA DUE TO DEGENERATIVE ARTHRITIS. NO COMPLICATIONS INDICATED. METAL ION TESTING WAS DONE ON (B)(6) 2015 AND FOUND TO BE EXTREMELY ELEVATED (52.8 MCG/L CO AND 39.3 MCG/L CR). REVISION OP NOTES INDICATE PATIENT UNDERWENT REVISION THA DUE TO MECHANICAL FAILURE OF A MOM HIP. UPON OPENING, THERE WAS NO EVIDENCE OF INFECTION BUT THERE WAS SOME GRAYISH SYNOVIAL LINING CONSISTENT WITH A MOM IMPLANT BUT NOT A PSEUDOTUMOR. THE TAPER ON THE STEM HAD EVIDENCE OF CORROSION WITH BLACK DISCOLORATION. THERE WAS NO EVIDENCE OF LOOSENING ON THE FEMORAL COMPONENT AND NO OSTEOLYSIS ON THE PROXIMAL FEMUR. CUP WAS REMOVED WITHOUT SIGNIFICANT DIFFICULTY AND SOME OSTEOLYSIS WAS NOTED IN THE SYMPHYSIS AREA BUT IT WAS MINIMAL. ANOTHER SMALL OSTEOLYTIC MEMBRANE WAS FOUND ALONG THE ANTERIOR FEMORAL WALL. NO COMPLICATIONS UPON IMPLANTATION OF THE NEW COMPONENTS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 BY LEGAL COUNSEL THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY FOURTEEN YEARS POST-IMPLANTATION DUE TO ALLEGED PAIN, ELEVATED COBALT LEVELS AND FLUID AROUND THE JOINT. MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED DUE TO MECHANICAL FAILURE AND METAL ON METAL. GRAYISH SYNOVIAL LINING, BLACK DISCOLORATION AND OSTEOLYTIC MEMBRANE WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669036 M2A-T M/H RAD SLD/APX SHL 50MM HIP, PROSTHESIS KWA ZIMMER BIOMET, INC. 241490

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R