BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM RECAP CUP

    MDR report key: 9860369 · Received March 20, 2020

    Report

    Report Number
    0001825034-2020-01200
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    February 21, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER ASSESSMENT IT WAS DETERMINED THAT THE INFECTION OCCURRED GREATER THAN ONE YEAR POST-OPERATIVELY. THEREFORE, THIS EVENT IS NOT REPORTABLE AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON FURTHER ASSESSMENT IT WAS DETERMINED THAT THE INFECTION OCCURRED GREATER THAN ONE YEAR POST-OPERATIVELY. THEREFORE, THIS EVENT IS NOT REPORTABLE AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT WAS NOT RETURNED BY PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 139256/TAPER/ LOT # 004320. ITEM # 157446/ HEAD/ /LOT # 368210 . ITEM # 192012/ STEM / /LOT # 011470. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -01197. 0001825034 -2020 -01198. 0001825034 -2020 -01199.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY DUE TO INFECTION. 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
    322098 M2A-MAGNUM RECAP CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 213330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R