BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X35MM

    MDR report key: 6891972 · Received September 25, 2017

    Report

    Report Number
    0001825034-2017-07354
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    July 23, 2010
    Report Date
    January 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: XL-156233, ARCOMXL 36MM RLC LNR +5MM SZ23, 091180, 103533, RINGLOC TI LOW PROFILE SCREW 6.5X30MM, 013680, PT-106054, REGENEREX RINGLOC+ REV CUP 54MM SZ 23, 295720. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07041, 0001825034 - 2017 - 07353, 0001825034 - 2017 - 07040.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION AFTER A FALL. IT WAS REPORTED TWO OF THE ACETABULAR SCREWS HAD FRACTURED; HOWEVER, THE SCREWS WERE NOT REVISED AS THERE WAS NO HARM TO THE PATIENT, PER THE SURGEON. THE ACETABULAR CUP AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672268 TI LOW PROFILE SCREW 6.5X35MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 567400

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R