BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SHOULDER COGR HUMERAL HEAD 52 X 26

    MDR report key: 114752 · Received August 22, 1997

    Report

    Report Number
    2935620-1997-00022
    Event Type
    Injury
    Date Received
    August 22, 1997
    Date of Event
    July 26, 1997
    Report Date
    August 22, 1997
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY-HEAD DISASSOCIATED FROM THE STEM. ON 07/14/1996, PATIENT WAS INVOLVED IN A MOTORCYCLE ACCIDENT WHEREIN HE SUSTAINED INJURY TO HIS RIGHT SHOULDER. HE WAS ADMITTED TO THE HOSPITAL. ON 07/15/1996, X-RAYS REVEALED A COMMINUTED FOUR PART HUMERAL HEAD AND NECK FRACTURE. DOCTOR ATTEMPTED REDUCTIONS WHICH WERE UNSUCCESSFUL. AT THAT POINT IN TIME, ANOTHER DOCTOR WAS CONSULTED AND THEY DETERMINED THAT A PROSTHESIS WAS NECESSARY. WHEN PATIENT RETURNED ON 07/22/1996, FOR FOLLOW-UP CARE, HE REPORTED TO CONTINUE TO HAVE PAIN IN HIS SHOULDER. AFTER SOME DIAGNOSTIC TESTING, IT WAS ALLEGEDLY DETERMINED THAT THE MODULAR HEAD HAD DISLODGED FROM THE STEM. ON 07/26/1996, A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SHOULDER COGR HUMERAL HEAD 52 X 26 Implant SHOULDER IMPLANT PROSTHESIS HSD SULZER ORTHOPEDICS, INC. NA 1214625

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R 7500-00-005 HUMERAL STEM