BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +1.5 GR

    MDR report key: 3817568 · Received May 19, 2014

    Report

    Report Number
    1818910-2014-18991
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. DEPUY HAS RECEIVED INFORMATION STATING THAT THE DEPUY FEMORAL HEAD WAS USED IN CONJUNCTION WITH COMPETITOR CUP, INSERT AND SCREWS. MANUFACTURER: STRYKER, PRODUCT: PCS CLUSTHER SHELL 62081049; 9225914, PRODUCT: HEX SCREW 62905020; 921456 (QTY: 2), PRODUCT: HOODED INSERT 62836469; 9223798, 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

    PATIENT WAS REVISED TO ADDRESS A DISLOCATION THAT HAD NOT BEEN FIXED, WHICH CAUSED THE METAL HEAD TO WEAR THROUGH THE LINER CAUSING IT TO BREAK. IT IS ALSO NOTED THAT THE 2 SCREWS INVOLVED WERE ALSO BROKEN. THE ACETABULAR CUP, INSERT AND BOTH SCREWS WERE FOUND TO BE COMPETITOR PRODUCTS. (B)(4). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A DISLOCATION THAT HAD NOT BEEN FIXED, WHICH CAUSED THE METAL HEAD TO WEAR THROUGH THE LINER CAUSING IT TO BREAK. IT IS ALSO NOTED THAT THE 2 SCREWS INVOLVED WERE ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296880 ARTICUL/EZE BALL 28 +1.5 GR HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 649790025

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention