BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SUPER ACET. CUP 48MM

    MDR report key: 3895813 · Received June 26, 2014

    Report

    Report Number
    1818910-2014-22058
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    January 14, 2005
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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. 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

    ADDITIONAL NARRATIVE: CORRECTION: MANUFACTURING FACILITY: (B)(4). IT SHOULD BE NOTED THESE RECORDS WERE RECEIVED THROUGH A PFS. FORMAL LITIGATION HASN¿T BEEN FILED YET, SO THIS COMPLAINT ISN'T LEGAL. PFS ALLEGES PAIN , LOOSENING,AND MOBILITY PROBLEMS. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS IMPLANTED ON (B)(6) 1993. SHE WAS REVISED ON (B)(6) 2005 DUE TO A LOOSE CUP, CATCHING/POPPING NOISES, POLY WEAR, AND METALLOSIS. THE REVISION OPERATIVE NOTE CONFIRMED LOOSENING OF THE CUP AS THERE WAS NO BONY GROWTH SO THE CUP AND 2 SCREWS ARE BEING REPORTED. THE OPERATIVE NOTE ALSO STATED THE 2 SCREWS WERE BROKEN. THE LINER IS BEING REPORTED FOR POLY WEAR. IT IS REASONABLE TO CONCLUDE THE METALLOSIS IS SECONDARY TO THE POLY WEAR. DOI: (B)(6) 1993; DOR: (B)(6) 2005 (RIGHT HIP). 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. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE AVAILABLE INFORMATION, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    PFS AND MEDICAL RECORDS RECEIVED. IT SHOULD BE NOTED THESE RECORDS WERE RECEIVED THROUGH A PFS. FORMAL LITIGATION HASN¿T BEEN FILED YET, SO THIS COMPLAINT IS NOT LEGAL. PFS ALLEGES PAIN, LOOSENING,AND MOBILITY PROBLEMS. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS IMPLANTED ON (B)(6) 1993. SHE WAS REVISED ON (B)(6) 2005 DUE TO A LOOSE CUP, CATCHING/POPPING NOISES, POLY WEAR, AND METALLOSIS. THE REVISION OPERATIVE NOTE CONFIRMED LOOSENING OF THE CUP AS THERE WAS NO BONY GROWTH SO THE CUP AND 2 SCREWS ARE BEING REPORTED. THE OPERATIVE NOTE ALSO STATED THE 2 SCREWS WERE BROKEN. THE LINER IS BEING REPORTED FOR POLY WEAR. IT IS REASONABLE TO CONCLUDE THE METALLOSIS IS SECONDARY TO THE POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375047 UNKNOWN DEPUY SUPER ACET. CUP 48MM HIP ACETABULAR CUP JDI DEPUY IRELAND - 9616671 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention