BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 4143524 · Received October 6, 2014

    Report

    Report Number
    1644408-2014-00622
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    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 ALLEVIATE INSTABILITY AND IMPROVE THE RANGE OF MOTION IN THE PATIENT'S JOINT AFTER 4.3 MONTHS 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. 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 864C1411. A TOTAL OF (B)(4) COMPLAINTS HAVE BEEN SUBMITTED AGAINST THIS PART NUMBER WITH (B)(4) OF THESE COMPLAINTS FOR JOINT INSTABILITY. THE REMAINING COMPLAINTS ARE THE RESULT FROM OTHER ISSUES SUCH AS INFECTIONS, DISLOCATIONS AND PAIN. THE EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE RESULT OF PATIENT INSTABILITY IN THE JOINT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - THE PATIENT NEEDED A MORE STABLE GLENOSPHERE AND POLY INSERT TO INCREASE THE STABILIZATION OF THE IMPLANT. THE SURGEON SWITCHED OUT THE TWO COMPONENTS TO GET THE RIGHT RANGE OF MOTION TO BENEFIT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623278 RSP SHOULDER RSP GLENOID HEAD W/RETAINING SCREW/-4MM OFFSET 32MM KWS ENCORE MEDICAL, L.P. 864C1411

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 508-01-032, LOT 859C1046