BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 4469299 · Received January 30, 2015

    Report

    Report Number
    1644408-2015-00052
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 26, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DISLOCATION AFTER 3.2 YEARS IN VIVO. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. 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. 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 THE MAIN COMPONENT LISTED IN THE COMPLAINT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THERE ARE A TOTAL OF (B)(4) PRIOR COMPLAINTS AGAINST THE GLENOID HEAD THAT HAS 66 SIMILAR FAILURE MODE PERTAINING TO "DISLOCATION." THIS IS THE SECOND COMPLAINT FOR THE INCIDENT LOT NUMBER 862C1440. THIS INVESTIGATION IS LIMITED IN SCOPE BECAUSE THE EXPLANTED PRODUCT WAS NOT RETURNED TO DJO SURGICAL AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - DUE TO THE PATIENT'S GLENOSPHERE DISLOCATING. PLEASE REFERENCE (B)(4). FOR FIST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72593 RSP SHOULDER GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL KWS ENCORE MEDICAL, L.P. 862C1440

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 506-03-114,LOT 831C1052| 506-03-122,LOT 633C1010| 506-03-134,LOT 836C1019