BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A/C2A ACETABULAR SYSTEM

    MDR report key: 6511135 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02543
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 21, 2021
    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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS - M2A TAPER 37/28MM LINER/ PN 15-105000/ L N393430, M2A-T M/H RAD SLD/APX SHL 48MM/ PN 15-104048/ LN 830740, BI-METRIC CDH POR N/C 11X134/ PN 162309/ LN 447730. 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 REPORT: 0001825034-2017-02542.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A 28MM M2A MOD HEAD -3MM NK, PART # 11-163661 FROM LOT 529580, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE HEAD IS SCUFFED SUCH THAT PART OF THE FINISH HAS BECOME HAZY AND DULL. SCRATCHING AND DRIED DEBRIS WERE ALSO OBSERVED ON THE HEAD. A M2A TAPER 37/28MM LINER, PART # 15-105000 FROM LOT 393430, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE LINER IS ASSEMBLED WITH THE RETURNED CUP. THE FINISH OF THE INNER RADIUS HAS BECOME HAZY AND DULL. FOREIGN DEBRIS WAS ALSO OBSERVED ON THE INNER RADIUS. THE LINER IS SCRATCHED. ADDITIONAL INFORMATION PROVIDED DOES NOT CHANGE THE ROOT CAUSE OF THE PREVIOUS INVESTIGATION. 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. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 PATIENT'S LEGAL COUNSEL THAT PATIENT HAD A RIGHT HIP REVISION APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO REJECTION OF METAL ON METAL COMPONENTS. IT WAS FURTHER REPORTED THAT PATIENT HAD LARGE VISIBLE PSEUDOTUMORS, OSTEOLYSIS, AND BONY NECROSIS AS WELL AS METALLOSIS AND BONE LOSS.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293332 M2A/C2A ACETABULAR SYSTEM PROSTHESIS, HIP JDL BIOMET ORTHOPEDICS N/A 529580

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R SEE H10 NARRATIVE