BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MULTIHOLE W/GRIPTION 52MM

    MDR report key: 2823009 · Received November 7, 2012

    Report

    Report Number
    1818910-2012-26758
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K093646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT 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

    DURING IMPLANTATION OF CUP ON (B)(6) 2012, THE SURGEON INADVERTENTLY PUT THE PINNACLE TRI-SPIKE CUP THROUGH THE MEDIAL WALL OF THE PATIENTS ACETABULUM. THEN, A 52MM MULTI-HOLE GRIPTION CUP WAS PLACED WITH FOUR SCREWS. THE PATIENT DID WELL FOR A FEW WEEKS BEFORE THE CUP MIGRATED INTO THE MEDIAL WALL DEFECT, REQUIRING REVISION ON (B)(6) 2012. (RIGHT HIP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MULTIHOLE W/GRIPTION 52MM ACETABULAR CUP LPH DEPUY WARSAW 135251

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention