BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2844960 · Received November 14, 2012

    Report

    Report Number
    1644408-2012-00607
    Event Type
    Other
    Date Received
    November 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    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 WAS TO REMEDY AN UNSTABLE JOINT AFTER 2.9 YEARS OF PATIENT USE. 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 SHOW NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 51ST COMPLAINT FOR THIS PART NUMBER: 23 DUE TO DISLOCATION, EIGHT DUE TO INFECTION, SIX FOR DISSOCIATION, FOUR DUE TO A LOOSE JOINT, TWO FRACTURES, TWO FOR PAIN, ONE FOR LIMITED RANGE OF MOTION, ONE DUE TO TRAUMA, ONE NON-ASSEMBLY, ONE DUE TO WEAR, AND ONE FOR A CLICKING NOISE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE UNSTABLE JOINT WAS MOST LIKELY DUE TO THE PATIENT FALLING. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT FELL AND DISLOCATED THEIR REVERSE SHOULDER PROSTHESIS. AS A RESULT, THEY BECAME UNSTABLE. THE SURGEON REVISED THE HUMERAL SHELL, LINER, AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, +4MM OFFSET KWS ENCORE MEDICAL, L.P. 53993241

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention (B)(4), LOT UNK| (B)(4), LOT 54002358| (B)(4), LOT UNK| (B)(4), LOT 54015521