BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 8086722 · Received November 19, 2018

    Report

    Report Number
    0001825034-2018-10677
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 23, 2018
    Report Date
    August 2, 2019
    Manufacturer
    .
    Product Code
    KWY
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 11-301300 ARCOS CON SZ A STD 50MM LOT# 950060, ITEM# 11-300812 ARCOS 12X150MM SPL TPR DIST LOT# 781840, ITEM# 00877503202 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14 LOT# 2857160, ITEM# 00875704801 SHELL WITH CLUSTER HOLES POROUS 48 MM O.D. SIZE GG FOR USE WITH GG LINERS LOT# 63475757, ITEM# 00885100832 NEUTRAL LINER 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL LOT# 63475757. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 10676, 0001825034 - 2018 - 10675.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION 2 YEARS POST IMPLANTATION DUE TO DISLOCATION BETWEEN THE BODY AND THE DISTAL STEM LOOSENING RESULTING IN DISLOCATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925104 UNKNOWN SCREW PROSTHESIS HIP KWY . N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R