BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X54MM

    MDR report key: 8653524 · Received May 30, 2019

    Report

    Report Number
    0001825034-2019-02358
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    April 25, 2019
    Report Date
    September 24, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2019-02362.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2019-02362.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET BIOLOX HEAD, CAT# 12-115109, LOT# 2886313; BIOMET G7 CUP, CAT# 110010271, LOT# 3983154; BIOMET LINER, CAT# 110024467, LOT#058910; BIOMET STEM, CAT# 11-301300, LOT# 946930; BIOMET TAPER, CAT# 11-300920, LOT# 013480. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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 -2019 - 02359, 0001825034 -2019 - 02361.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A CLOSED REDUCTION OF A DISLOCATED RIGHT HIP APPROXIMATELY 1 YEAR POST IMPLANTATION. IT WAS FURTHER REPORTED THAT DURING THE REDUCTION, THE G7 BEARING DISASSOCIATED FROM THE BIOLOX HEAD. THIS LED TO A SECOND REVISION OF THE RIGHT HIP. IT WAS NOTED ESTIMATED BLOOD LOSS OF 100ML, SUBFASCIAL ADHESIONS NOTED DUE TO PREVIOUS INCISIONS, REDDISH SYNOVIAL FLUID NOTED (UNREMARKABLE), ANTERIOR OSTEOPHYTES NOTED AROUND THE ACETABULUM, WELL-FIXED ACETABULUM AND FEMORAL STEM, ADDUCTOR TENOTOMY PERFORMED DUE TO LIMITED RANGE OF MOTION PER PATIENT ANATOMY, NO INTRAOP COMPLICATIONS NOTED. 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
    447280 ACT ARTIC E1 HIP BRG 28X54MM PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 211710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R