BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 42MM 42MM

    MDR report key: 9255915 · Received October 30, 2019

    Report

    Report Number
    0001825034-2019-04892
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    March 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. INITIAL OP NOTES VERIFY THAT THE PATIENT HAD LEFT THA DUE TO OSTEOARTHRITIS. LEFT HIP NOT REVISED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157848 LOT 872810 M2A CUP 48X42MM, 103202 LOT 397710 FEMORAL STEM 7.5X135MM, 157442 LOT 729460 M2A HEAD 42MM, 139256 LOT 446680 M2A TAPER ADAPTER STDTIM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034 - 2019 - 04893.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT LEFT HIP ANTHROPLASTY. LEGAL COUNSEL FURTHER REPORTS PATIENT SUFFERS FROM METAL ON METAL COMPLICATIONS. NO REVISION HAS BEEN REPORTED FOR THE LEFT HIP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048740 M2A-MAGNUM MOD HD SZ 42MM 42MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 729460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other