BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND HIGHMO PE CUP D38 +3MM

    MDR report key: 3820737 · Received May 20, 2014

    Report

    Report Number
    1818910-2014-19117
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    DEPUY FRANCE SAS REG. # 3003895575
    Product Code
    KWS
    PMA / PMN Number
    PK081620
    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. PRODUCT DEVELOPMENT REVIEWED THE PROVIDED X-RAY AND STATED THERE IS NO OBJECTIVE EVIDENCE TO CONCLUDE ON A ROOT CAUSE OF THE DISLOCATION. A DEPUY (B)(4) SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO 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.

    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.

    Description of Event or Problem · 1

    PROCEDURE: REVISION OF A REVERSE TOTAL SHOULDER REPLACEMENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2014 AND REVISED ON (B)(6) 2014. REVISION SURGERY WAS UNDERTAKEN DUE TO A DISLOCATED SHOULDER. PATIENT PRESENTED TO SURGEON WITH DECREASED FUNCTION AND INVESTIGATIONS INDICATED A DISLOCATED SHOULDER. THE SURGERY WAS PERFORMED THROUGH A OPEN INCISION. THE POLYETHYLENE LINER WAS REMOVED AND A NEW SIZE 6MM LINER INSERTED. THE SHOULDER WAS THEN REDUCED AND THEN CLOSED. THE REMOVED IMPLANT WAS DISCARDED AS PER HOSPITAL PROTOCOL. IT IS NOT AVAILABLE FOR RETURN. PRE-OP X-RAY IS AVAILABLE. THE PATIENT DID NOT CONSENT TO HAVE THEIR POST OP NOTES TO BE PROVIDED FOR FURTHER INVESTIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300170 DXTEND HIGHMO PE CUP D38 +3MM SHOULDER BEARING KWS DEPUY FRANCE SAS REG. # 3003895575 5221551

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention