BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER

    MDR report key: 6700499 · Received July 11, 2017

    Report

    Report Number
    0001825034-2017-04708
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    June 13, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): A 51-106170 3587045 TAPERLOC COMPLETE MICROPLASTY STEM. A 11-165230 910750 RING LOC BI-POLAR ACETABULAR CUP 28 MM I.D. / 53 MM O.D. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 04673, 0001825034 - 2017 - 04706.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S HIP WAS REVISED APPROXIMATELY 8 MONTHS POST-IMPLANTATION DUE TO PAIN AND STEM MIGRATION. ALL IMPLANTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480988 MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER/ NO SKIRT PLUS 6 MM NECK TYPE I TAPER PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 488360

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R