BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CRVD INSRT SZ2.5 8MM

    MDR report key: 2834468 · Received November 15, 2012

    Report

    Report Number
    1818910-2012-26827
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    PMA / PMN Number
    K943462
    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. RADIOGRAPHIC INFORMATION WAS NOT AVAILABLE. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED POLYETHYLENE WEAR WITHOUT THE PRODUCT TO EXAMINE. 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 AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    **UPDATE** 03/12/2013 - PATIENT'S MEDICAL RECORDS WERE RECEIVED (B)(4) 2013. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. MEDICAL RECORDS WERE OBTAINED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    **UPDATE** (B)(4) 2013 - X-RAYS WERE RECEIVED. THE COMPLAINT WAS RE-OPENED. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. RADIOGRAPHIC IMAGES WERE PROVIDED FOR REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED POLYETHYLENE WEAR AND FRACTURE OF THE DEVICE WITHOUT THE PRODUCT TO EXAMINE. HOWEVER, DUE TO THE LENGTH OF TIME BETWEEN DATE OF INSERTION AND DATE OF REVISION, IT WOULD NOT BE UNEXPECTED TO OBSERVE POLY WEAR AS IT WAS DESCRIBED WITHIN THE COMPLAINT. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES REVISION DUE TO A TIBIAL INSERT THAT WAS SO WORN IT BROKE. (LEFT KNEE)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CRVD INSRT SZ2.5 8MM TIBIAL INSERT JWH DEPUY IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention