BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLOC TRIPOLAR 41MMOD28MMIDSZ26

    MDR report key: 7339511 · Received March 14, 2018

    Report

    Report Number
    0001825034-2018-01907
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    April 15, 2011
    Report Date
    May 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK991990
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 163662, 28MM MOD HD STD NECK TP1 TAPER, 063130, 11-301351, ARCOS CON SZ A HI 80MM, 983940, 11-165112, ALL-POLY TRI POLAR CUP 26X60MM, 627910, 11-300615, ARCOS 15X200MM PRX TPR DIST, 956670. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 2018 - 01908. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THE EVENT WILL BE REPORTED ON 0001825034-2017-11431.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180408 RLOC TRIPOLAR 41MMOD28MMIDSZ26 PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 781610

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R