BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 6772036 · Received August 7, 2017

    Report

    Report Number
    0001825034-2017-05959
    Event Type
    Injury
    Date Received
    August 7, 2017
    Report Date
    August 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(6). MEDICAL PRODUCTS: UNKNOWN HEAD, UNKNOWN CUP, UNKNOWN STEM; THERAPY DATE: UNKNOWN. LITERATURE- SUEYOSHI, T., KEATING, E. M., RITTER, M. A., MEDING, J. B., & BRUNSMAN, M. J. (2016). EARLY CLINICAL OUTCOMES WITH A 3-D POROUS TITANIUM ACETABULAR CUP. OPEN JOURNAL OF ORTHOPEDICS, 06(06), 121-125. DOI:10.4236/OJO.2016.66018. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AND PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPOTS WERE FILED FORTHIS EVENT. PLEASE SEE ASSOCIATED REPORTS:0001825034-2014-09203-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO DISLOCATION ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551718 UNKNOWN LINER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention