BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 56MM

    MDR report key: 3063785 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15506
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT FELT A "POP" A FEW MONTHS AGO AND BEGAN TO EXPERIENCE HIP PAIN. UPON SURGERY, THE LINER WAS FOUND TO HAVE DISASSOCIATED FROM THE CUP, AND SHOWED WEAR AND DEFORMATION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. AN X-RAY WAS OBTAINED BUT DOES NOT CONFIRM THE REPORT OR PROVIDE ROOT CAUSE. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    PATIENT FELT A "POP" A FEW MONTHS AGO AND BEGAN TO EXPERIENCE HIP PAIN. UPON SURGERY, THE LINER WAS FOUND TO HAVE DISASSOCIATED FROM THE CUP, AND SHOWED WEAR AND DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165988 PINNACLE 100 ACET CUP 56MM ACETABULAR CUP LPH 1818910 DEPUY ORTHOPAEDICS, INC. A6BF61

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention