BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 3180047 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00330
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS THE PATIENT'S SCAPULA CRACKED DUE TO POOR BONE QUALITY. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. 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 ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT: (B)(4) INVOLVED PRODUCT THAT WAS MARKED WITH THE WRONG LOT NUMBER. THE PART WAS REWORKED AND REMARKED WITH THE CORRECT LOT NUMBER AND THEN ACCEPTED. (B)(4). THE ROOT CAUSE FOR THE BROKEN SCAPULA DURING SURGERY WAS DUE TO POOR BONE QUALITY. THE SURGEON MENTIONED AN MRI SHOULD HAVE BEEN PERFORMED PRIOR TO THE SURGERY TO DETERMINE THE PATIENT'S BONE DENSITY. THERE IS NO INDICATION OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    PRIMARY SURGERY - WHEN THE SURGEON WAS INSERTING THE REVERSE SHOULDER PROSTHESIS BASE PLATE THE PT'S SCAPULA CRACKED DUE TO POOR BONE QUALITY. THE SURGEON MENTIONED SHE SHOULD HAVE DONE AN MRI TO DETERMINE THE DENSITY OF PT'S BONES PRIOR TO THE SURGERY. DUE TO THIS ISSUE THE CASE WAS CHANGED FROM A REVERSE SHOULDER PROSTHESIS TO A HEMI SHOULDER. SIGNIFICANT ADVERSE EVENT REPORTED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268448 NONE KWS ENCORE MEDICAL, L.P. 866C1545

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R