BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK INSERT

    MDR report key: 3172881 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19039
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    HSH
    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. HOWEVER, THE INITIAL REPORTING INDICATES THAT THE SURGEON DOES NOT FIND THE DEPUY PRODUCT TO BE THE SOURCE OF PAIN OR LOOSENING. THE PATIENT WAS IMPLANTED (B)(6) 1997 AND REVISED ON (B)(6) 2013. IT IS NOT LIKELY THE DEVICE CONTRIBUTED TO THE PATIENTS REPORTED INFECTION 15 YEARS AFTER IMPLANTATION. REVIEW OF PROVIDED PATIENT X-RAY FINDS NOTHING OUTWARD TO SUGGEST ROOT CAUSE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN AND POSSIBLE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273456 UNK INSERT TIBIAL INSERT HSH DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention