BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END MODULAR HUM STEM D12 HA

    MDR report key: 3915560 · Received July 7, 2014

    Report

    Report Number
    1818910-2014-22734
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575
    Product Code
    HSD
    PMA / PMN Number
    PK071379
    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND AN INITIAL CONFORMANCE OF THESE PRODUCTS WITH REGARDS TO THE SPECIFICATIONS. REVIEW OF THE STERILE CERTS FOUND NO ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. ORIGINAL SURGERY DATE WAS THE ONLY ADDITIONAL INFORMATION PROVIDED. 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

    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.

    Description of Event or Problem · 1

    PROCEDURE: REVISION DELTA XTEND SHOULDER. PATIENT PRESENTED WITH AN INFECTION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2014. OPERATION PERFORMED ? REMOVAL OF DELTA XTEND IMPLANTS AND INSERTION OF A ANTIBIOTIC CEMENT SPACER. ADDITIONAL PROSTHESIS EXPLANTED WERE: REF:130720102. LOT:5012765 AND REF:130712000. LOT:5036451. THE EXPLANTED PROSTHESIS WERE SENT FOR PATHOLOGY INVESTIGATIONS. THEY ARE NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. PRE OPERATION X-RAYS ARE AVAILABLE. PATIENT GENDER AND DOB ARE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393507 END MODULAR HUM STEM D12 HA SHOULDER HUMERAL STEM/EPIPHYSIS HSD DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575 5036451

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention