BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 3961147 · Received July 28, 2014

    Report

    Report Number
    1644408-2014-00478
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K950594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMOVE A SHOULDER PROSTHESIS AFTER THE FAILURE OF THE PATIENT'S ROTATOR CUFF; AFTER 3.7 YEARS OF PATIENT USE. NO INFORMATION WAS REPORTED WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE (B)(4) COMPLAINT AGAINST LOT NUMBER 53997559. A TOTAL OF (B)(4) COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER NONE OF WHICH HAVE A SIMILAR FAILURE. INFORMATION WAS NOT PROVIDED THAT DEFINITIVELY IDENTIFIED THE ROOT CAUSE FOR THE ROTATOR CUFF FAILURE. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT SUFFERING FROM A FAILED ROTATOR CUFF 3.5 YEARS AFTER HER TOTAL SHOULDER. THE SURGEON DETERMINED SHE WOULD BE REVISED TO A REVERSE SHOULDER PROSTHESIS. THE SURGEON REMOVED THE ORIGINAL IMPLANTS AND PERFORMED A REVERSE TOTAL SHOULDER AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439262 FOUNDATION SHOULDER STANDARD HUMERAL HEAD HSD ENCORE MEDICAL, L.P. 53997559

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention (B)(4), LOT A1000000| (B)(4), LOT 742C1003