BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX54MM CUP

    MDR report key: 16832431 · Received April 28, 2023

    Report

    Report Number
    0001825034-2023-00921
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    February 16, 2005
    Report Date
    April 27, 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). CONCOMITANT MEDICAL PRODUCTS: 21-124311 ¿ MH STEM ¿ 520500. 11-173660 ¿ M2A HEAD ¿ 963380. REPORT SOURCE AUSTRALIA. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. 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. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A SECOND REVISION SURGERY APPROXIMATELY 1 YEAR AFTER THE FIRST DUE TO LOOSENING. 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
    490103 M2A 38MMX54MM CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 691730

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H