BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 3161888 · Received June 6, 2013

    Report

    Report Number
    1644408-2013-00315
    Event Type
    Other
    Date Received
    June 6, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 25, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS THE PATIENT BEING UNSTABLE AFTER ONE MONTH OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. THERE WAS NO INFORMATION WITH THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE PATIENT'S INSTABILITY. 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 BY THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THREE NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT: NCMR #16362 WAS ISSUED TO ADDRESS VISUAL DISCREPANCIES ON THE HUMERAL FORGINGS, ALL OF THE PARTS WERE ACCEPTED, NCMR #15830 WAS ASSOCIATED WITH THE HUMERAL FORGINGS DUE TO AN OVERSIZED FEATURE, ALL PARTS WERE RETURNED TO THE VENDOR, AND NCMR #14118 INVOLVED THREE PARTS THAT WERE OUT OF TOLERANCE; ALL THREE PARTS WERE SCRAPPED. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 25TH COMPLAINT FOR THIS PRODUCT: THREE REVISION SURGERIES, TWO DUE TO DISLOCATION, ONE DUE TO WEAR/EXCESSIVE WEAR, THREE DUE TO PAIN, FIVE DUE TO TRAUMA, ONE FOR DEVICE LOOSENING, AND TEN FOR STABILITY/POOR JOINT ISSUES. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE INSTABILITY COULD NOT BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS REPORTED UNSTABLE, SO THE SURGEON CONVERTED FROM A HEMI TO A REVERSE SHOULDER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250471 FOUNDATION SHOULDER PRIMARY HUMERAL STEM, MALE TAPER KWS ENCORE MEDICAL, L.P. 764C1018

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 500-04-142: LOT 741C1002| 503-42-022: LOT 53999919