BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MULTIHOLE II CUP 50MM

    MDR report key: 6135850 · Received November 30, 2016

    Report

    Report Number
    1818910-2016-32551
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    October 19, 2016
    Report Date
    November 29, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MRA
    PMA / PMN Number
    P070026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). 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

    EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE REPORTED DISASSOCIATION. MACHINING LINES ON THE ARTICULATING LINER SURFACE COUNTER TO THE VISIBLE BEARING WEAR SUGGESTS THE DEVICE WAS NOT EVENLY LOADED BY THE FEMORAL HEAD. IT IS SUSPECTED THE ACETABULAR CUP WAS POSITIONED MORE VERTICALLY THAN RECOMMENDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO RELATED REPORTS AGAINST THE DEVICE PRODUCT/LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DISASSOCIATION OF THE POLYETHYLENE LINER WAS FOUND. THE PRIMARY SURGERY WAS CONDUCTED ABOUT ONE YEAR AND A HALF AGO. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE DISASSOCIATION OF THE POLYETHYLENE LINER WAS FOUND.

    Description of Event or Problem · 1

    THE DISASSOCIATION OF THE POLYETHYLENE LINER WAS FOUND. THE PRIMARY SURGERY WAS CONDUCTED ABOUT ONE YEAR AND A HALF AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786835 PINNACLE MULTIHOLE II CUP 50MM N/A MRA DEPUY ORTHOPAEDICS, INC. 519778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention