BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 8435903 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-00947
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 1, 2019
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #139254 M2A-MAGNUM 42-50MM TPR INSRT-3 LOT #221470, ITEM # UNKNOWN UNKNOWN CUP LOT # UNKNOWN, ITEM # UNKNOWN UNKNOWN STEM LOT # UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REGARDING PROVIDED OP NOTES: THE SURGEON PROVIDES NO INDICATION IN HIS DICTATION AS TO WHY THE TOTAL HIP FAILED, STATES NO EVIDENCE OF PSEUDOCAPSULE AND NO BURNISHING OF THE FEMORAL TRUNNION. THE FEMUR AND ACETABULUM WERE WELL-FIXED. NO INTRAOP COMPLICATIONS OR SIGNIFICANT FINDINGS NOTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE DEVICE WAS DETERMINED TO BE CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY NINE YEARS POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO INCREASING METAL ION LEVELS. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NO INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231041 M2A-MAGNUM MOD HD SZ 44MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 721070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R