BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD 44 MM HEAD DIAMETER

    MDR report key: 6746406 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05198
    Event Type
    Injury
    Date Received
    July 27, 2017
    Report Date
    December 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05200, 0001825034-2017-05199, 0001825034-2017-05201. CONCOMITANT PRODUCTS: M2A-MAGNUM PF CUP PN: US157850 LN: 296840, TAPERLOC POROUS STEM PN: 11-103204 LN: 615600, M2A-MAGNUM TAPER BODY PN: 139254 LN: 338140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS SCHEDULED FOR A RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527693 M2A-MAGNUM MODULAR HEAD 44 MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 352790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention