BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +13 BLK

    MDR report key: 3212284 · Received July 9, 2013

    Report

    Report Number
    1818910-2013-20713
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    JDI
    PMA / PMN Number
    PK883460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE CUP AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. MEDICAL RECORDS WERE OBTAINED. FROM A MEDICAL PERSPECTIVE IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. ALL TOTAL HIP ARTHROPLASTIES HAVE A RISK OF FAILURE THAT IS RELATED TO PATIENT FACTORS, SURGICAL PROCESS AND SURGICAL TECHNIQUE. IT APPEARS THE OLD ACETABULAR CUP WAS WELL OUT OF THE RANGE OF 40-45 DEGREES OF ABDUCTION THAT IS CURRENTLY RECOMMENDED IN THE SURGICAL TECHNIQUE AND MAY HAVE INCREASED THE RISK OF DISLOCATION. THE INVESTIGATION COULD NOT DRAW ANY FURTHER CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314337 ARTICUL/EZE BALL 32 +13 BLK FEMORAL HEAD JDI 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH D13012837

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention