BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 6629401 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03569
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 24, 2016
    Report Date
    June 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S):- CER OPT TYPE 1 TPR SLEVE 0MM/ PN 650-1066/ LN 326490. CER BIOLOXD OPTION HD 36MM/ PN 650-1057/ LN 132420. MLRY-HD POR FMRL 10X155MM/ PN 11-104110/ LN 397470. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03565, 0001825034-2017-03567, 0001825034-2017-03568.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001822565-2017-04287.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY EIGHT MONTHS POST IMPLANTATION DUE TO PATIENT ALLEGATIONS OF PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412872 UNKNOWN CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R