BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +6

    MDR report key: 3912011 · Received July 3, 2014

    Report

    Report Number
    1818910-2014-22612
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. OTHER REPORTS WERE FOUND IN A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATIONS. PER PROCEDURE, THESE DEVICES ARE EXEMPT FROM DHR REVIEW. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ABOVE IMPLANTS WERE REMOVED DURING REVISION SURGERY (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390561 S-ROM M HEAD 36MM +6 HIP FEMORAL HEAD LPH DEPUY INTERNATIONAL LTD. REG. # 8010379 2938010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention