BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X30MM

    MDR report key: 7758544 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05174
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 8, 2013
    Report Date
    August 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ITEM # UNK, STEM, LOT # UNK, ITEM # 650-1059, HEAD, LOT # 173430, ITEM # 11-104052, SHELL, LOT # 983640, ITEM # EP-108625, LINER, LOT # 869410, ITEM # 103531, SCREW, LOT # 619150, ITEM # 103531, SCREW, LOT # 619150, ITEM # 103531, SCREW, LOT # 762760, ITEM # 103531, SCREW, LOT # 476910, ITEM #103532, SCREW, LOT# 619200, ITEM # 650-1066, TAPER ADAPTER, LOT #623480. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05172, 0001825034 - 2018 - 05173, 0001825034 - 2018 ¿ 05174, 0001825034-2018-08604, 0001825034-2018-08603, 0001825034-2018-08602, 0001825034-2018-08601. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEW CONFIRMS THAT THE CUP MIGRATED INTO THE RIGHT HEMIPELVIS. THE ACETABULAR FIXATION SCREWS ARE FRACTURED. THERE IS ALSO A NEW FRACTURE OF THE RIGHT INFERIOR PUBIC RAMUS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, STEM, LOT # UNK; ITEM # 650-1059, HEAD, LOT # 173430; ITEM # 11-104052, SHELL, LOT # 983800; ITEM # EP-108625, LINER, LOT # 869410; ITEM # 103532, SCREW, LOT # UNK; ITEM # 103531, SCREW, LOT # UNK; ITEM # 650-1066, TAPER ADAPTER, LOT #623480. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05171, 0001825034 - 2018 - 05172, 0001825034 - 2018 - 05173.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 YEAR POST REVISION, PATIENT UNDERWENT A SECOND REVISION DUE TO MIGRATION OF THE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597940 TI LOW PROFILE SCREW 6.5X30MM HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 440330

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R