BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 8258667 · Received January 17, 2019

    Report

    Report Number
    0001825034-2019-00107
    Event Type
    Injury
    Date Received
    January 17, 2019
    Report Date
    June 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: EXPIRATION DATE CORRECT. AN M2A-MAGNUM MOD HD SZ 50MM, PART # 157450 FROM LOT 959590, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE HEAD TO BE ASSEMBLED WITH THE HEAD UPON RECEIPT. BOTH THE HEAD AND TAPER INSERT ARE COVERED IN DRIED YELLOW LIQUID. NO OBSERVATIONS COULD BE MADE IN REGARDS TO THE CONDITION OF THE SURFACE OF THE HEAD. DEBRIS IS PRESENT INSIDE THE INSERT'S TAPER. THE DEBRIS COULD NOT BE VISUALLY DIFFERENTIATED FROM THE REMAINDER OF THE DRIED FILM ON THE HEAD. THE EXPOSED FACE OF THE INSERT 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 · 0

    CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: US157856 LOT NUMBER:921710 BRAND NAME:M2A MAGNUM CUP, CATALOG NUMBER:157450 LOT NUMBER:959590 BRAND NAME: M2A MAGNUM HEAD, CATALOG NUMBER:X11-180316 LOT NUMBER:425400 BRAND NAME: BIMETRIC STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FAILED LEFT HIP CAUSED BY ADVERSE LOCAL REACTION TO METAL ON METAL WITH MULTIPLE SYMPTOMS. DURING THE PROCEDURE, PSEUDOTUMOR WAS IDENTIFIED AND EXCISED. PRE-OPERATIVE BLOOD WORK SHOWED THAT PATIENT HAD ELEVATED METAL IONS - CR AT 12.7 AND CO AT 16.3. MRI SHOWED METAL DEBRIS AND ADVERSE REACTION. ADVERSE TISSUE REACTION WAS FOUND THROUGHOUT THE JOINT WITH NEUROLYSIS OF LEFT SCIATIC NERVE. THERE WAS BONE LOSS ON THE SUPERIOR POSTERIOR ASPECT OF THE ACETABULUM. OSTEOLYSIS WAS NOTED AT THE ANTERIOR INFERIOR PORTION OF THE ACETABULUM, POSTERIOR PORTION OF THE STEM, AND AT GREATER TROCHANTER. THE CUP AND HEAD WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    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: UNKNOWN M2A CUP, UNKNOWN STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00105. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, BONE DESTRUCTION, METALLOSIS AND METAL WEAR APPROXIMATELY 8 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52435 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 959590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R