BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 58MM

    MDR report key: 3880356 · Received June 18, 2014

    Report

    Report Number
    1818910-2014-21393
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 29, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    UDI: (B)(4). 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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE LINER AND/OR FEMORAL HEAD. PER PROCEDURE, THIS DEVICE(S) IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. MEDICAL RECORDS NEED REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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.

    Description of Event or Problem · 1

    LITIGATION RECEIVED. LITIGATION ALSO ALLEGES DISCOMFORT. A DOI WAS PROVIDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2016.

    Description of Event or Problem · 1

    UPDATE - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE PFS REPORTS LIMITED MOBILITY, STIFFNESS, AND DIFFICULTY AMBULATING. THE REVISION SURGERY NOTES METAL SYNOVITIS, VERTICAL ACETABULAR SHELL, VARUS POSITION STEM WITH THE DISTAL ASPECT OF THE STEM ERODING INTO THE ENDOSTEAL CORTEX OF THE LATERAL SHAFT OF THE FEMUR. THE ESTIMATED BLOOD LOSS WAS 1600CC, AND THERE WAS METAL DEBRIS AND ELEVATED METAL ION LEVELS WERE REPORTED. THE PATIENT'S RIGHT HIP IS A POLY ON METAL HIP, BUT NO MANUFACTURER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357098 PINNACLE 300 ACET CUP 58MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US ZP3EP1000

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention