BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 SHOULDER PLATE 3 HOLE LEFT

    MDR report key: 2251032 · Received August 26, 2011

    Report

    Report Number
    1818910-2011-16136
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Report Date
    August 1, 2011
    Manufacturer
    DEPUY ACE S.A.'R.L.
    Product Code
    LXT
    PMA / PMN Number
    K060290
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, THERE ARE 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 DVA-104443-DFMEA AND DVA-104443-RMR AND IS APPROVED WITH AN IFR (INVESTIGATE FURTHER REDUCTION) DESIGNATION. THE ENGAGEMENT ISSUES ARE IMPACTED BY PATIENT ANATOMY AND SURGICAL TECHNIQUE. 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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. (B)(4) WAS OPENED ON (B)(4) 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 (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

    THE PEGS WOULD NOT ENGAGE THE THREADED HOLES IN THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S3 SHOULDER PLATE 3 HOLE LEFT 87LXT LXT DEPUY ACE S.A.'R.L. NA RM051A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR