BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2864307 · Received December 5, 2012

    Report

    Report Number
    1644408-2012-00642
    Event Type
    Other
    Date Received
    December 5, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER THREE WEEKS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED 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 SHOWS THIS IS THE 52ND COMPLAINT FOR THIS PART NUMBER: 24 DUE TO DISLOCATION, EIGHT DUE TO INFECTION, SIX DISSOCIATIONS, FOUR FOR LOOSE JOINT, TWO FRACTURES, TWO DUE TO PAIN, ONE LIMITED RANGE OF MOTION, ONE DUE TO TRAUMA, ONE NON-ASSEMBLY, ONE DUE TO WEAR, AND ONE FOR A CLICKING NOISE. THIS IS THE SECOND COMPLAINT FOR THIS LOT NUMBER DUE TO TRAUMA/FRACTURED BONE. THE ROOT CAUSE FOR THE DISLOCATION WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. SEVERAL FACTORS NOT RELATED TO THE IMPLANT CAN PLAY A ROLE IN DISLOCATION SUCH AS; LOOSE JOINT FROM INADEQUATE SOFT TISSUE AND PATIENT ACTIVITY. 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 SUFFERED A DISLOCATION; NEEDED A +8 SOCKET SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, +4MM OFFSET KWS ENCORE MEDICAL, L.P. 852C1073

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 508-32-104, LOT 866C1347| 508-00-032, LOT 855C1113| 506-03-130, LOT 835C1050| 415-00-060, LOT 7710111-16| 508-32-101, LOT 862C1139| 506-03-130, LOT 835C1023| 506-03-126, LOT 834C1055| 506-03-130, LOT 835C1020| 506-00-012, LOT 817C1059