BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7611348 · Received June 18, 2018

    Report

    Report Number
    0001825034-2018-03945
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    May 25, 2018
    Report Date
    July 5, 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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157850, M2A-MAGNUM PF CUP 50ODX44ID, 138890. THE 11-103206, TAPERLOC POR LAT FMRL 12.5X145, 279150. THE 139252, M2A-MAGNUM 42-50 MM TPR INSRT-6, 946360. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03961. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [REMAINS IMPLANTED]. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. X-RAY REVIEW CONFIRMS THE DISLOCATION.THERE IS QUESTIONABLE LUCENCY WITHIN THE ACETABULUM ABUTTING THE ACETABULAR COMPONENT THAT MAY REPRESENT OSTEOLYSIS IN ZONES I AND II. DEVICE HISTORY RECORD (DHR) 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 · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP CLOSED REDUCTION PROCEDURE 11 YEARS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452424 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 970730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R