BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X35MM

    MDR report key: 8629814 · Received May 21, 2019

    Report

    Report Number
    0001825034-2019-02286
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    July 18, 2006
    Report Date
    August 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 #139247, ENDO II TAPER INSERT STD 0MM T, LOT #699430; ITEM # 12-139030, ENDO II MOD ENDO HEAD SZ 53, LOT #889560; ITEM #11-105864, ARCOM 28MM RLOC LNR 10D/HWL 24, LOT #185510; ITEM # 135256, VISION RINGLOC SHELL 56MM SZ24, LOT#723050; ITEM #163662, MODULAR HEAD, LOT #239570; ITEM #103534, PROFILE SCREW, LOT #036310; ITEM #103533, PROFILE SCREW, LOT #473770. 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: 0001825034-2019-02245, 0001825034-2019-02285, 0001825034-2019-02289.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT LEFT REVISION TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY APPROXIMATELY TWO (2) MONTHS POST OP THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO HIP FAILURE RESULTING FROM ALLOGRAFT COLLAPSE IN ACETABULAR REGION AND LOOSENING OF THE CUP. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422737 TI LOW PROFILE SCREW 6.5X35MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 950810

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R MEDICAL PRODUCTS