BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +6MM

    MDR report key: 4100685 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28434
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    3003895575 DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    PK062250
    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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DATE RECEIVED BY MFG. MANUFACTURE DATE. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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.

    Description of Event or Problem · 1

    SHOULDER REVISION PERFORMED ON (B)(6) 2014 BY DR AT (B)(6). ORIGINAL SURGERY DONE ON (B)(6) 2004 (SAME SURGEON AND HOSPITAL). THE PATIENT HAD DISLOCATED THE SHOULDER AND IT WAS ABLE TO BE RELOCATED BY MANIPULATION UNDER ANAESTHETIC BUT WOULD NOT REMAIN IN POSITION . THE SURGEON THEN DECIDED TO OPERATE AND CHANGE THE PE CUP AND ADDED A SPACER. OTHER IMPLANTS WHICH REMAINED IN SITU: REF 130770018 LOT 2733367, REF 30770018 LOT 2753958, REF 130760138 LOT 2669405. PATIENT INITIALS (B)(6), DOB (B)(6) 1935.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582604 DXTEND STAND PE CUP D38 +6MM SHOULDER BEARING HSD 3003895575 DEPUY FRANCE 2739475

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention