BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 48MM

    MDR report key: 8531439 · Received April 19, 2019

    Report

    Report Number
    0001825034-2019-01761
    Event Type
    Injury
    Date Received
    April 19, 2019
    Date of Event
    February 26, 2016
    Report Date
    July 30, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: BIOMET M2A CUP CATALOG#US157854 LOT#425290, BIOMET ECHO STEM CAT#192514 LOT#922400, BIOMET M2A INSERT CAT#139254 LOT#461530. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -01760.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, INFLAMMATION, ELEVATED ION METALS, METALLOSIS. 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
    324975 M2A-MAGNUM MOD HD SZ 48MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 846420

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BIOMET M2A CUP, CATALOG# US157854, LOT#425290| UNKNOWN STEM| BIOMET M2A CUP, CATALOG# US157854, LOT#425290| UNKNOWN STEM