BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM 44MM

    MDR report key: 16911016 · Received May 11, 2023

    Report

    Report Number
    0001825034-2023-01042
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    September 19, 2022
    Report Date
    June 2, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: MECHANICAL (G04)- HEAD. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MEDICAL RECORDS REVIEW INDICATES AN INITIAL LEFT THA WAS PERFORMED ON (B)(6) 2011. A REVISION WAS PERFORMED ON (B)(6) 2022 DUE TO PAIN AND ELEVATED METAL IONS. METALLOSIS WAS NOT PRESENT WITHIN THE JOINT, BUT THERE WAS EFFUSION. THE HEAD AND TAPER ADAPTER WERE REMOVED AND EXCHANGED WITH NO COMPLICATIONS NOTED. 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 · 0

    (B)(4). D10: US157850 ¿ M2A MAGNUM CUP ¿ 989170, 192508 ¿ ECHO STEM ¿ 909680, 139254 ¿ M2A TAPER INSERT ¿ 767400. PRODUCT WILL NOT BE RETURNING TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS NOT RETURNED BY THE ATTORNEY. THE INVESTIGATION IS IN PROCESS. 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 - 2023 - 01041.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 11 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED METAL IONS. DURING THE REVISION, EFFUSION AND SCAR TISSUE WAS SEEN WITHIN THE JOINT. THE HEAD WAS EXCHANGED WITHOUT COMPLICATION AND A POLYETHYLENE LINER WAS PLACED. 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
    1406311 M2A-MAGNUM MOD HD SZ 44MM 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 297020

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R