BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND STAND PE CUP D38 +6MM

    MDR report key: 2875054 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83407
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. 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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR BOTH OF THE PROVIDED PART AND LOT NUMBER COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX C. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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 EMDR HAS BEEN SUBMITTED TO THE FDA ON (B)(4), BUT DUE TO FDA PROCESSING PROBLEMS THEY NEVER RECEIVED ACK2 OR ACK3. THE FDA ASKED US TO RESUBMIT THEM TODAY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND STAND PE CUP D38 +6MM HUMERAL CUP KWS 3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST 5200235

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention