BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 6632505 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03746
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    December 21, 2015
    Report Date
    May 18, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6:COMPONENT CODE: MECHANICAL (G04) - HEAD. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A M2A-MAGNUM MOD HD SZ 54MM, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE HEAD REMAINS ASSEMBLED WITH THE INSERT. THE EXPOSED FACE AND TAPER OF THE INSERT ARE SCRATCHED. THE INSERT IS ETCHED -3. THE OUTER RADIUS IS SCUFFED. A LARGE PORTION OF THE OUTER RADIUS IS COVERED IN A THIN DRIED FILM. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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

    THE COMPLAINT NUMBER CORRESPONDING TO THIS MEDWATCH IS (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. CONCOMITANT PRODUCT(S): - US157860 M2A-MAGNUM PF CUP 711680. A 192014 ECHO POR FMRL 390740. A 157454 M2A-MAGNUM MOD HD 595250. A 139270 M2A-MAGNUM 52-60MM 525860. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03743 & 0001825034-2017-03746.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: M2A-MAGNUM PF CUP 60ODX54ID CATALOG#: US157860 LOT#: 711680; M2A MAGNUM TPR ADPR TI DIA52-60/+3MMT1 CATALOG#: 139270 LOT#: 525860; BI-METRIC ECHO PC 14X150 CATALOG#: 192014 LOT#: 390740. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE INFORMATION CONTAINED WITHIN THIS REPORT DOES NOT ALTER PREVIOUS INVESTIGATION CONCLUSION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENTS LEGAL COUNSEL THAT THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO METALLOSIS AND MOM. MEDICAL RECORDS NOTED EXTERNAL BULGING, TURBID GRAY FLUID, PSEUDOTUMOR AND METALLOSIS. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410978 M2A-MAGNUM MOD HD SZ 54MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 595250

    Patients

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