BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT44IDX66OD

    MDR report key: 2870603 · Received December 12, 2012

    Report

    Report Number
    1818910-2012-29175
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 23, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    **UPDATE** 11/23/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO INFECTION, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT, SWELLING IN THE LEG, AND DIFFICULTY SLEEPING. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATIONS AND DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. 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 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

    (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. **UPDATE** 11/23/2012 - LITIGATION PAPERS RECEIVED. IN ADDITION TO INFECTION, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT, SWELLING IN THE LEG, AND DIFFICULTY SLEEPING.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS GROSS INFECTION AND HYPERTROPHIC SCAR. REVISION NOTES REPORTED THAT THERE WAS A FULL BLOWN OUTWARD FLOW OF PUS AFTER EXCISION OF THE FASCIA AND REMOVING THE CALCAR COMPONENT MADE FRACTURES AND CRACKS AND QUARTER SIZE BONE LOSS IN THE DIRECT LATERAL PART OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT44IDX66OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 2374870

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention