BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNWON FEMORAL HED

    MDR report key: 7634853 · Received June 25, 2018

    Report

    Report Number
    0001822565-2018-03404
    Event Type
    Injury
    Date Received
    June 25, 2018
    Report Date
    April 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS NOT CONFIRMED YET X-RAY REVIEW DEMONSTRATED EXTENSIVE POSTOPERATIVE CHANGE INVOLVING THE ACETABULUM WITH FIXATION PINS AND SCREWS AS WELL AS BONE GRAFT/CEMENT EXTENDING MEDIALLY INTO THE HEMIPELVIS. THE ACETABULAR COMPONENT OF THE LEFT HIP ARTHROPLASTY HAS ROTATED APPROXIMATELY 90 DEGREES IN A COUNTER-CLOCKWISE DIRECTION WITH THE CUP OPENING NOW PROJECTING SUPEROLATERALLY. THE COMPONENTS ARE DISLOCATED SECONDARY TO THIS ROTATION. NO FRACTURE IS IDENTIFIED. 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. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- UNKNOWN LINER, UNKNOWN CUP, UNKNOWN STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-03403, 0001822565-2018-03402, 0001822565-2018-03405. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478831 UNKNWON FEMORAL HED PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R