BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM M2A MOD HEAD -6MM NK

    MDR report key: 6522258 · Received April 26, 2017

    Report

    Report Number
    0001825034-2017-02754
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    February 18, 2016
    Report Date
    September 27, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDL
    PMA / PMN Number
    PK042841
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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 CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS - 11-104107 MLRY-HD POR FMRL 7X140MM, 15-104050 M2A-T M/H RAD SLD/APX SHL 50MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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 0001825034-2017-02755.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS¿ 11-163660 28 MM M2A MOD HEAD -6 MM NK LOT 388080; 15-105000 M2A TAPER 37/28 MM LINER LOT 763680; 11-104107 MLRY-HD POR FMRL 7 X 140 MM LOT 413410; 15-104050 M2A-T M/H RAD SLD/APX SHL 50 MM 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    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.

    Description of Event or Problem · 1

    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
    305532 28MM M2A MOD HEAD -6MM NK PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A 388080

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R