BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED HIP IMPLANTENDURON LINER 44¿OD-22¿ID

    MDR report key: 3875315 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21063
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    NOTIFICATION WAS RECEIVED FROM BIOENGINEERING STATING THAT THE ROOT CAUSE IS UNDETERMINED. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE NEED FOR REVISION WAS UNDETERMINED. THE CUSTOMER DID NOT REPORT A DEVICE DEFECT. IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A MANUFACTURING FAULT. NO CORRECTIVE ACTION IS REQUIRED. A COMPLAINTS DATABASE SEARCH CONDUCTED ON THE PRODUCT NUMBER PROVIDED DID NOT IDENTIFY ANY ANOMALIES. A COMPLAINT SEARCH COULD NOT BE CONDUCTED ON THE OTHER PRODUCT AS NO PRODUCT NUMBERS WERE PROVIDED. A REVIEW OF MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS NO LOT NUMBERS WERE PROVIDED. THE COMPLAINT SHALL BE CLOSED WITH A JUSTIFIED CONCLUSION IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS. 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

    THE PATIENT WAS REVISED DUE TO METALLOSIS ON (B)(6) 2014. THE ORIGINAL THA SURGERY WAS CONDUCTED AT 1997 IN ANOTHER HOSPITAL. IN THE SURGERY, IT WAS FOUND THE SHELL WAS BREAKAGE AND THE SURROUNDING SOFT TISSUE WAS NECROSED WHICH WAS SUSPECTED AS METALLOSIS BECAUSE OF POLY WEAR. IN ADDITION, IT WAS FOUND THAT OSTEOLYSIS ON THE FEMUR. HOWEVER, THERE ARE NOT FOUND LOOSENING OF STEM, SO THE CASE WAS COMPLETED BY CONDUCTING ACETABULAR¿S RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352512 UNIDENTIFIED HIP IMPLANTENDURON LINER 44¿OD-22¿ID HIP ACETABULAR INSERT/LINER JDI DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention