BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 6201581 · Received December 22, 2016

    Report

    Report Number
    1644408-2016-01034
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    October 2, 2015
    Report Date
    February 6, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    UDI-DI
    00888912024600
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS INSTABILITY. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 9.2 MONTHS. 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 HAS NOT BEEN MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED. THE ROOT CAUSE FOR THE JOINT INSTABILITY WAS NOT REPORTED. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT'S ORIGINAL SURGERY ((B)(4)) TOOK PLACE ON (B)(6) 2014. ANOTHER ((B)(4)) TOOK PLACE ON (B)(6) 2014. ANOTHER REVISION ((B)(4)) TOOK PLACE ON (B)(6) 2015. THE LAST SURGERY TOOK PLACE ON (B)(6) 2016. ALL REVISIONS TOOK PLACE BECAUSE THE PATIENT WAS UNSTABLE AND THE SURGEON KEPT INCREASING THE GLENOID SIZE IN ORDER TO TRY TO MAKE THE JOINT STABLE. HE WAS UNSUCCESSFUL, THUS REMOVING ALL DJO IMPLANTS, ACCORDING TO THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848942 RSP SHOULDER GLENOID, HEAD W/RETAINING SCREW, RSP, 36MM, NEUTRAL KWS ENCORE MEDICAL, L.P. 869C1254 00888912024600

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 506-03-114, LOT 831C1217| 506-03-130, LOT 835C1169| 508-00-036, LOT 856C1097| 508-36-101, LOT 869C1254