BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEGS

    MDR report key: 2111402 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08614
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT SEARCH WAS ALSO COMPLETED AND FOUND PREVIOUS COMPLAINTS FOR THIS FAILURE MODE. PATIENT ANATOMY AND SURGICAL TECHNIQUE CAN IMPACT THE PEG ENGAGEMENT EVEN IF THE PRODUCT IS WITHIN SPECIFICATION. THIS IS DISCUSSED IN (B)(4) AND IS APPROVED WITH AN IFR (INVESTIGATE FURTHER REDUCTION) DESIGNATION. ALTHOUGH THE RISK IS CONSIDERED ACCEPTABLE PER THE RMR (RISK MANAGEMENT REPORT), PRODUCT DEVELOPMENT, QUALITY AND MARKETING ARE INVESTIGATING WAYS TO FURTHER REDUCE THE OCCURRENCE OF PEG ENGAGEMENT ISSUES. CAPA (B)(4) WAS OPENED ON MAY 10, 2011 TO DETERMINE IF ANY ADDITIONAL ACTIONS MAY DECREASE THE LIKELIHOOD OF PEG ENGAGEMENT ISSUES. ANY ROOT CAUSE AND/OR CORRECTIVE ACTIONS WILL BE DOCUMENTED IN CAPA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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 WAS REVISED DUE TO SCREWS BACKING OUT OF S3 PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PEGS NONE HRS DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention