BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 44MM

    MDR report key: 7797798 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08306
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A MAGNUM CUP, CATALOG #: US157850, LOT #: 011000, M2A MAGNUM HEAD, CATALOG #: 157444, LOT #: 368540, ECHO FEMORAL, CATALOG #: 192412, LOT #: 262570. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED WITH NO DEVIATIONS IDENTIFIED. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. MULTIPLE MDR REPORTS WERE FILED, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08306, 0001825034-2018-10832. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # US157850, CUP, LOT # 011000. ITEM # 139261, TAPER INSERT, LOT # 244230. ITEM # 192410, STEM, LOT # 262570.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 8 YEARS POST IMPLANTATION DUE TO PAIN AND ELEVATED ION LEVELS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637820 M2A-MAGNUM MOD HD SZ 44MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 368540

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R