BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 54MM

    MDR report key: 16645082 · Received March 30, 2023

    Report

    Report Number
    0001825034-2023-00709
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    December 14, 2022
    Report Date
    June 23, 2023
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT THA WAS PERFORMED ON (B)(6) 2007. A REVISION OCCURRED ON (B)(6) 2022 DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION BLACK DISCOLORATION WAS NOTED TO THE TISSUES AND THE STEM AND TAPER ADAPTOR WERE COLD WELDED TOGETHER. ALL IMPLANTS EXCEPT THE STEM WERE EXPLANTED AND REPLACED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157860 M2A-MAGNUM PF CUP 60ODX54ID LOT NUMBER: 354890, 139264 2A-MAGNUM 52-60MM TPR INSRT-6 LOT NUMBER: 568020, X11-180318 BI-METRIC/X POR NC LAT 18X170 LOT NUMBER: 635890. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00712, 0001825034 - 2023 - 00711, 0001825034 - 2023 - 00708. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PT UNDERWENT A REVISION PROCEDURE 15 YEARS AND 7 MONTHS POST-IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION IT WAS NOTED THE PATIENT HAD BLACK DISCOLORATION TO SYNOVIAL TISSUE AND TAPER ADAPTER COLD WELDED TO TRUNNION. ALL COMPONENTS EXCHANGED WITHOUT COMPLICATIONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172772 M2A-MAGNUM MOD HD SZ 54MM PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 473990

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Required Intervention| H