BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 50MM

    MDR report key: 5830640 · Received July 28, 2016

    Report

    Report Number
    0001825034-2016-02763
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    April 21, 2016
    Report Date
    January 27, 2021
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 139259 M2A MAGNUM 42-50M TPR INSRT +6 347220, US157856 M2A-MAGNUM PF CUP 56OD/50ID 948390, 11-103206 TAPERLOC POR LAT FMRL 12.5X145 860050. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATIONS OR ANOMALIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE ADDITIONAL INFORMATION CONTAINED WITHIN THIS REPORT HAVE NO EFFECT ON PREVIOUS INVESTIGATION CONCLUSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND VISUAL EXAMINATION OF DEVICE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A M2A-MAGNUM MOD HD SZ 50MM, PART # 157450 FROM LOT 832650, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE OUTER RADIUS OF THE HEAD TO BE SCRATCHED AND WORN. THE HEAD REMAINS ASSEMBLED WITH A TAPER ADAPTER. THE EXPOSED FACE OF THE ADAPTER IS SCRATCHED. SCRATCHING AND A WHITE RING OF DEBRIS WERE OBSERVED INSIDE THE TAPER OF THE ADAPTER. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NEW INFORMATION DOES NOT CHANGE THE PREVIOUS INVESTIGATION RESULTS. 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

    PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED ELEVATED METAL ION LEVELS, HIP PAIN, GROIN PAIN, BACK RASH, CLICKING, AND BLURRED VISION.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO ALLEGED ELEVATED METAL ION LEVELS, HIP PAIN, GROIN PAIN, BACK RASH, CLICKING, AND BLURRED VISION. OPERATIVE REPORT NOTED SOME GRAY TINGING TO THE SOFT TISSUES, AND THERE WAS A FAIRLY PROLIFIC SYNOVITIS PRESENT. THERE WAS SOME INFERIOR AND SOME SLIGHT POSTERIOR OSTEOPHYTES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481137 M2A MAGNUM MODULAR HEAD 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 832650

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R