BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M 28MM HEAD +6

    MDR report key: 3402707 · Received October 10, 2013

    Report

    Report Number
    1818910-2013-30042
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    March 23, 2009
    Report Date
    January 24, 2014
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK893872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. NO ADDITIONAL EVENT INFORMATION OR INVESTIGATIONAL INPUTS WERE PROVIDED TO CUSTOMER QUALITY. AS THE CASE IS IN LITIGATION, FOLLOW UP FOR THIS ADDITIONAL INFORMATION WILL BE PERFORMED BY DEPUY LEGAL. A SEARCH OF THE COMPLAINTS DATABASES FINDS ONE OTHER REPORT AGAINST THE 2254028 LOT CODE FOR DISLOCATION. IT IS NOT KNOWN IF THE REPORTS ARE SIMILAR AS THE REASON FOR REVISION HAS NOT BEEN PROVIDED. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) FOR PRODUCT NUMBER 136518500 LOT NUMBER 2254028 FOUND NO ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CONFIRMED REVISION OF PINNACLE/S-ROM MOM HIP. REASON FOR REVISION UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516182 S-ROM M 28MM HEAD +6 FEMORAL HEAD JDI 8010379 DEPUY INTL., LTD. 2254028

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention