BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 7827491 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08604
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    July 8, 2013
    Report Date
    August 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 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 # 103533, SCREW, LOT # 440330; 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, 0001825034-2018-08603, 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. THERE IS A LINEAR PIECE OF BONE ALONG THE LATERAL ASPECT OF THE PROXIMAL FEMUR NEW SINCE PRIOR EXAMS WITH MILD CONTOUR DEFORMITY OF THE ADJACENT FEMUR AND THIS MAY ALSO REPRESENT A FRACTURE FRAGMENT OR AREA OF HETEROTOPIC OSSIFICATION. DEVICE HISTORY RECORD (DHR) 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.

    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. X-RAYS IDENTIFIED A FRACTURE OF THE FEMUR AND HETEROTOPIC OSSIFICATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671441 UNKNOWN STEM HIP PROSTHESIS JDI ZIMMER BIOMET, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R