BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 10064964 · Received May 18, 2020

    Report

    Report Number
    0001825034-2020-01906
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    December 2, 2019
    Report Date
    July 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K051569
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G4, G7, H2, H3, H6, H10. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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). CONCOMITANT MEDICAL DEVICES: BIOMET CUP, CAT#: US157852, LOT#: 473320; BIOMET STEM, CAT#: 103204, LOT#: 103204; BIOMET TAPER ADAPTER, CAT#: 139252, LOT#: 974030. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01905.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY APPROXIMATELY 12 YEARS AGO. THE PATIENT WAS REVISED LAST YEAR DUE TO PAIN. DURING THE PROCEDURE IT WAS NOTED THE PATIENT¿S IMPLANT HAD LOOSENED, THERE WAS PRESENCE OF SCAR TISSUE, AND METAL STAINING. 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
    529299 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 739140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R SEE H10 NARRATIVE.