BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED GLENOID PEG

    MDR report key: 3053510 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15270
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE PROVIDED PATIENT X-RAYS INDICATE THE HUMERAL HEAD IS MIGRATING SUPERIORLY, WHICH IS CONSISTENT WITH CUFF TEAR AND CONFIRMS THE REPORT. CUFF TEAR IS A COMMON PROGRESSION OF THE DISEASED SHOULDER AND THERE IS NOTHING INDICATING THAT THE IMPLANTS ARE FAULTY. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISION DUE TO CUFF TEAR THE GLENOID PEG (5 PEG) PRODUCT CODE IS NOT KNOWN BECAUSE THE POLYETHYLENE IS WORN OFF AND THE WRITING HAS BEEN WORN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156300 UNIDENTIFIED GLENOID PEG GLENOID KWS DEPUY ORTHOPAEDICS 563150

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention