BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 4091814 · Received September 16, 2014

    Report

    Report Number
    1644408-2014-00560
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON THE REVISION SURGERY WAS PERFORMED WAS TO ALLEVIATE PATIENT JOINT LOOSENESS AFTER 1.4 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. 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 FIRST COMPLAINT AGAINST LOT NUMBER 864C1208. (B)(4). THE REMAINING COMPLAINTS HAVE RESULTED FROM OTHER ISSUES SUCH AS INFECTIONS, DISLOCATIONS AND PATIENT CONTRAINDICATIONS. THE ROOT CAUSE FOR THIS PRODUCT COMPLAINT WAS A REVISION SURGERY PERFORMED TO ALLEVIATE PATIENT JOINT LOOSENESS RESULTING FROM PATIENT POOR BONE QUALITY THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE LOOSENING OF THE IMPLANTS CAUSED BY POOR BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573289 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW / -4MM OFFSET 32MM KWS ENCORE MEDICAL, L.P. 864C1208

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R 508-32-104, LOT 866C1468| 506-03-118, LOT 832C1060| 506-03-118, LOT 832C1079| 508-00-032, LOT 855C1182| 506-03-134, LOT 836C1042| 506-03-134, LOT 836C10383