BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STEM

    MDR report key: 8335024 · Received February 13, 2019

    Report

    Report Number
    0001822565-2019-00613
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 4, 2019
    Report Date
    February 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS RECEIVED. X-RAY REVIEW IDENTIFIED SUPEROLATERAL SUBLUXATION OF THE PROSTHETIC FEMORAL HEAD IN RELATION TO THE ACETABULAR CUP SECONDARY TO SEVERE POLYETHYLENE LINER WEAR. THERE ARE EXTENSIVE RADIOLUCENCIES ALONG THE ACETABULAR CUP AND ACETABULAR FIXATION SCREWS CONSISTENT WITH OSTEOLYSIS. THERE ARE SMALL SCATTERED AREAS OF RADIOLUCENCY ALONG THE PROXIMAL FEMORAL COMPONENT ALSO CONSISTENT WITH OSTEOLYSIS. THERE IS NO EVIDENCE OF FRACTURE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: LINER 0001822565 - 2019 - 00150 - 2, CUP 0001822565 - 2019 - 00610, SCREW 0001822565 - 2019 - 00612.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT HIP REVISION DUE TO LINER WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130401 UNKNOWN STEM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN CUP| UNKNOWN LINER| UNKNOWN SCREW