BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SROM SUPER GRIPPER CUP

    MDR report key: 3830502 · Received May 23, 2014

    Report

    Report Number
    1818910-2014-19430
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 25, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PROCEDURE: TOTAL HIP REVISION. REVISION OCCURED ON 11 APRIL 2014. REASON: UNKNOWN. EXPLANTS ARE SROM SUPER GRIPPER CUP, LINER AND HEAD. FEMORAL STEM IS STILL IMPLANTED. NO PHOTOS OR X-RAY AVAILABLE. NO MEDICAL REPORTS OR OPERATIVE NOTES AVAILABLE. PATIENT INITIALS, DOB AND GENDER ARE PROVIDED. NO FURTHER INFORMATION AVAILABLE. UPDATE 23RD APRIL 2014. REASON FOR REVISION: POLYETHYLENE WEAR & OSTEOLYSIS. ORIGINAL SURGERY PERFORMED IN: 1989. THERE ARE NO ORIGINAL OPERATIVE NOTES (PRODUCT CODES ETC) AVAILABLE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND 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

    ADDITIONAL NARRATIVE: 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

    PROCEDURE: TOTAL HIP REVISION. REVISION OCCURED ON (B)(6) 2014. REASON: UNKNOWN. EXPLANTS ARE SROM SUPER GRIPPER CUP, LINER AND HEAD. FEMORAL STEM IS STILL IMPLANTED. NO PHOTOS OR X-RAY AVAILABLE. NO MEDICAL REPORTS OR OPERATIVE NOTES AVAILABLE. PATIENT INITIALS, DOB AND GENDER ARE PROVIDED. NO FURTHER INFORMATION AVAILABLE. UPDATE (B)(4) 2014. REASON FOR REVISION: POLYETHYLENE WEAR & OSTEOLYSIS. ORIGINAL SURGERY PERFORMED IN: 1989. THE HOSPITAL IS UNKNOWN. THERE ARE NO ORIGINAL OPERATIVE NOTES (PRODUCT CODES ETC) AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308086 UNKNOWN SROM SUPER GRIPPER CUP HIP ACETABULAR CUP JDI DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention