BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +5 BR

    MDR report key: 2792568 · Received October 16, 2012

    Report

    Report Number
    1818910-2012-22647
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    November 28, 2011
    Report Date
    October 5, 2012
    Manufacturer
    DEPUY SUZHOU
    Product Code
    JDI
    PMA / PMN Number
    K843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED CONSTRAINING RING CONFIRMS A FRACTURE TO THE MATERIAL AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS FINDS NO RELATED DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE LINER OR THE KNOWN FEMORAL HEADS PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THERE IS EVIDENCE OF IMPINGEMENT ON THE RETURNED DEVICE. IMPINGEMENT DAMAGE IS ALSO REPORTED IN THE PROVIDED PATIENT MEDICAL RECORD. IMPINGEMENT OF THE FEMORAL STEM AGAINST THE LINER AND CONSTRAINING RING WHILE IN-SITU WOULD PLACE UNEXPECTED AND UNINTENDED PRESSURES ON THE MATERIAL. THE INVESTIGATION IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTS FRACTURE OF THE RETAINING RING. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. THE REVISION OPERATIVE REPORT INDICATED THAT THE PATIENT WAS REVISED ON MULTIPLE OCCASIONS TO ADDRESS CHRONIC DISLOCATION. ON (B)(6) 2011, IT WAS NOTED INTRAOPERATIVELY THAT THE RING WAS OFF THE LINER. ON (B)(6) 2012, IT WAS NOTED THAT THE PATIENT BROKE THE RING IN HIS CONSTRAINED HIP. UPDATE: PATIENT REPORTED ON 8/17/2012 THAT HE WAS REVISED AGAIN ON (B)(6) 2012 TO ADDRESS ANOTHER BROKEN CONSTRAINING RING. UPDATE: (B)(6) 2012 - ADDITIONAL PATIENT RECORDS WERE RECEIVED. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICUL/EZE BALL 32 +5 BR TOTAL HIP REPLACEMENT JDI DEPUY SUZHOU D11120246

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention