BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3932718 · Received July 14, 2014

    Report

    Report Number
    1818910-2014-23285
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 31, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 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

    PATIENT HAD A PINNACLE MODULAR METAL INSERT IN AND WAS HAVING PAIN, AND DR. (B)(6) REVISED HER BY TAKING THE METAL INSERT OUT AND CHANGING TO A POLY LINER AND A NEW FEMORAL HEAD. HE ALSO REMOVED A 6.5 SCREW OUT OF THE ACETABULAR CUP. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT HAD A PINNACLE MODULAR METAL INSERT IN AND WAS HAVING PAIN, AND DR. (B)(6) REVISED HER BY TAKING THE METAL INSERT OUT AND CHANGING TO A POLY LINER AND A NEW FEMORAL HEAD. HE ALSO REMOVED A 6.5 SCREW OUT OF THE ACETABULAR CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409111 S-ROM M HEAD 36MM +3 HIP FEMORAL HEAD LPH DEPUY INTERNATIONAL LTD. 8010379 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention