BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D42 +9MM

    MDR report key: 3802768 · Received May 9, 2014

    Report

    Report Number
    1818910-2014-18448
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 20, 2014
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    KWS
    PMA / PMN Number
    PK120174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWS AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THEIR SPECIFICATION. FOR THESE BATCHES, THERE WAS NO DEVIATION OR NON-CONFORMANCE. THE STERILE CERTIFICATES WERE REVIEWED; NO ANOMALIES WERE DETECTED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280332 DXTEND STAND PE CUP D42 +9MM SHOULDER BEARING KWS 3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST 5200261

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention