BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +9 BL

    MDR report key: 3190380 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19892
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 30, 2013
    Report Date
    July 10, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    JDI
    PMA / PMN Number
    PK843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    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. CLINICAL REPORT STATES THE PATIENT EXPERIENCED AN INITIAL DISLOCATION. THE LEFT HIP SUBLUXED ANTERIORLY. THE PATIENT UNDERWENT A CLOSED REDUCTION AND MANIPULATION. DOI: (B)(6) 2013 DOR: NO REVISION (LEFT HIP). UPDATE (B)(4) 2013 - CLINICAL REPORT WAS RECEIVED. REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATIONS. THE PATIENT DISLOCATED ON (B)(6) 2013. 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. REQUESTS MADE PREVIOUSLY FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A FOR REPORTS INVOLVING THE SAME PATIENT, ALSO ALLEGING DISLOCATION. NO ADDITIONAL INFORMATION WAS OBTAINED. MEDICAL RECORDS WERE OBTAINED WITH THE INITIAL REPORTING AND HAVE BEEN REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A 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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT EXPERIENCED AN INITIAL DISLOCATION. THE LEFT HIP SUBLUXED ANTERIORLY. THE PATIENT UNDERWENT A CLOSED REDUCTION AND MANIPULATION. UPDATE: (B)(6) 2013 - CLINICAL REPORT WAS RECEIVED. REPORT INDICATES THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATIONS. THE PATIENT DISLOCATED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291147 ARTICUL/EZE BALL 32 +9 BL HEAD JDI 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH D12113510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention