BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +3MM

    MDR report key: 5662477 · Received May 18, 2016

    Report

    Report Number
    1818910-2016-19474
    Event Type
    Injury
    Date Received
    May 18, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 10, 2016
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED TO THE COMPLAINT WERE NOT RETURNED FOR ANALYSIS. THE DHR ANALYSIS PERFORMED FOR BATCH 5258193 AND 5262750 DID NOT REVEAL ANY ANOMALIES THAT COULD BE RELATED TO THE ISSUE REPORTED ON THE COMPLAINT. THE DHR REVIEW ON THE REPORTED (PRODUCT CODE 110006100, LOT NUMBER 7982650) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODES AND LOTS COMBINATIONS. NO X-RAY OR OPERATIVES NOTES WERE PROVIDED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS VERY SMALL AND THE SMALLEST UNCEMENTED SIZE HUMERAL IMPLANT WAS IMPLANTED. POST OPERATIVELY AFTER THE PATIENT HAD BEEN DISCHARGED THE HUMERUS FRACTURED AND THE JOINT DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318336 DXTEND STAND PE CUP D38 +3MM SHOULDER BEARING KWS DEPUY FRANCE SAS 3003895575 5262750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention