BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7764601 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-05070
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    October 3, 2012
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN, UNKNOWN LINER LOT# UNKNOWN, ITEM# UNKNOWN, UNKNOWN SCREW LOT# UNKNOWN. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES WHICH INDICATED PATIENT UNDERWENT REVISION DUE TO INSTABILITY IN LEFT LEG, SUBLUXATION AND DISLOCATION. DEVICE HISTORY RECORD (DHR) 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. ADDITIONAL MDR ASSOCIATED TO EVENT: 0001825034 - 2018 - 09667.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO INSTABILITY AND MULTIPLE SUBLUXATIONS/DISLOCATION. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: EP-105994 ¿ E-POLY 36MM RINGLOC MAX-ROM ACETABULAR LINER ¿ 893400; 11-104056 - M/H SLD/APX HLE RNGLC SHL 56MM ¿ 952470; 15-103203 - TAPERLOC MICROP LAT FMRL 9.0MM - 016960. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05072.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO INSTABILITY. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. 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
    602773 M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 771170

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R