BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OFFSET CUP IMPACTOR

    MDR report key: 4787582 · Received May 19, 2015

    Report

    Report Number
    9614497-2015-00123
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 29, 2015
    Report Date
    September 14, 2015
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS YET TO BE RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. ONCE GREATBATCH MEDICAL COMPLETE THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED. COMPLAINT INFORMATION WAS PROVIDED BY (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO GREATBATCH FOR EVALUATION SO THE REPORTED EVENT COULD NOT BE CONFIRMED. A PROCESS REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. NO FURTHER INVESTIGATION REQUIRED. SHOULD COMPLAINT SAMPLE BE RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    DURING A PRIMARY HIP RIGHT SIDE PROCEDURE, THE OFFSET CUP IMPACTOR BROKE. A SMALL PIECE FROM THE UNIVERSAL JOINT WAS LOST WITHIN THE PATIENT WOUND. THE SURGEON CHECKED UNDER X-RAY AND WAS UNABLE TO EXTRACT THE PIECE FROM THE PATIENT. CUSTOMER REPORTS THE PIECE REMAINS IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324255 OFFSET CUP IMPACTOR IMPACTOR HWA GREATBATCH MEDICAL SA T6318 726797001-15

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other