BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 46ODX40ID

    MDR report key: 7948723 · Received October 9, 2018

    Report

    Report Number
    0001825034-2018-09501
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    September 14, 2015
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NONE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: TAPERLOC POR LAT FMRL 5.0X130 30, PN 11-103200, LN 425890, PSELEX/MAGNUM MOD HD 40MM -6, PN S061140 LN 821700. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-09502, 0001825034-2018-09571. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 UNDERWENT A RIGHT HIP REVISION APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO METALLOSIS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787731 M2A-MAGNUM PF CUP 46ODX40ID PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 658780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R