BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1

    MDR report key: 19566228 · Received June 19, 2024

    Report

    Report Number
    0001825034-2024-01640
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    October 17, 2023
    Report Date
    September 5, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT #: US157850 / M2A-MAGNUM PF CUP 50ODX44ID / LOT #: 642860. CAT #: 15744 / M2A-MAGNUM MOD HD SZ 44MM; 44MM / LOT #: 059620. CAT #: 13-103208 / TAPERLOC POR RED/LAT 15X150 / LOT #: 974640. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-01639, 0001825034-2024-01624, 0001825034-2024-01641. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: METALLOSIS AND INSTABILITY. DARK JOINT FLUID, METAL STAINING OF TISSUE, BONE LOSS, PSEUDOTUMOR. SIGNIFICANT OSTEOLYSIS WAS CONFIRMED. ACETABULAR COMPONENT WAS WELL FIXATED. THE COMPLAINT WAS CONFIRMED BASED ON THE EVALUATION OF THE PROVIDED MEDICAL RECORDS. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY FIFTEEN YEARS POST IMPLANTATION DUE TO INSTABILITY WITH RECURRENT POSTERIOR DISLOCATIONS AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, METAL RELATED PATHOLOGY WAS CONFIRMED BY EXTENSIVE METAL STAINING OF THE TISSUE ALONG WITH SIGNIFICANT FEMORAL BONE LOSS AND A MODERATELY SIZED PSEUDOTUMOR WAS CONFIRMED. ALONG THESE LINES, SIGNIFICANT OSTEOLYSIS WAS FOUND ALONG THE FEMORAL COMPONENT AND INSTABILITY WAS FOUND WITH THE ACETABULAR COMPONENT. BONE GRAFTING WAS PERFORMED TO ACHIEVE A GOOD FIT WITH THE NEW ACETABULAR COMPONENT. NO FURTHER COMPLICATIONS WERE NOTED. ALL OF THE COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626456 M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 145840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H