BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX54MM CUP

    MDR report key: 17006165 · Received May 25, 2023

    Report

    Report Number
    0001825034-2023-00718
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    February 23, 2004
    Report Date
    March 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-173662 ¿ M2A HEAD ¿ 714180. 21-124311 ¿ M/H FEMORAL STEM ¿ 520500. G2: REPORT SOURCE AUSTRALIA. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE HEAD IS COVERED IN BIO DEBRIS. NO DAMAGE CAN BE SEEN. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00717.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO DISLOCATION. 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
    1515580 M2A 38MMX54MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 691730

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.