BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 52MM

    MDR report key: 7207305 · Received January 19, 2018

    Report

    Report Number
    0001825034-2018-00302
    Event Type
    Injury
    Date Received
    January 19, 2018
    Report Date
    January 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BI-METRIC/X POR NC 15X155 LOT #722310, ITEM# X180315, M2A-MAGNUM 52-60MM TPR INS STD LOT#681870, ITEM#139268, M2A-MAGNUM 52-60MM TPR INS STD LOT#010290 ITEM#US157858. REMAINS IMPLANTED. THE REPORTED EVENT IS CONFIRMED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE COMPATIBILITY CHECK NOTED NO ISSUES. X-RAY REVIEW IDENTIFIED NO HARDWARE FAILURE. THE MEDICAL RECORD REVIEW IDENTIFIED THAT THE PATIENT'S LEFT LEG APPEARED SHORTER. THE NOTES ALSO CONFIRMED PAIN AND AUDIBLE NOISE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00303, 0001825034-2018-00304.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT HIP ARTHROPLASTY AND EXPERIENCED PAIN SIX YEARS POST OPERATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THE DEVICE THAT CAUSED OR CONTRIBUTED TO THIS EVENT COULD NOT BE DETERMINED BY THE PHYSICIAN; THEREFORE, ALL DEVICES ARE BEING REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51092 M2A-MAGNUM MOD HD SZ 52MM HIP, PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 433420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention