BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32

    MDR report key: 7380959 · Received March 29, 2018

    Report

    Report Number
    0009613350-2018-00400
    Event Type
    Injury
    Date Received
    March 29, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INVOLVED DEVICE IS ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32 MANUFACTURED BY ZIMMER INC., WARSAW. SAME/SIMILAR DEVICES ARE NOT CLEARED FOR USE IN THE U.S, THEREFORE THIS REPORT WILL BE INVALIDATED. PLEASE INVALIDATE THIS CASE FROM YOUR SYSTEM. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INVOLVED DEVICE IS ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32 MANUFACTURED BY ZIMMER INC., WARSAW. SAME/SIMILAR DEVICES ARE NOT CLEARED FOR USE IN THE U.S, THEREFORE THIS REPORT WILL BE INVALIDATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ALLOCLASSIC CUP, REF# UNKNOWN, LOT# UNKNOWN. THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: 0009613350-2018-00399. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. NOTE: THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225986 ALLOCLASSIC VARIALL BIOLOX DELTA, INSERT, II/32 UNKNOWN KWY ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R