BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN S3 SHOULDER PLATE

    MDR report key: 2111501 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08701
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    October 5, 2010
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    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

    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

    (B)(4). THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE UNAVAILABLE. ALTHOUGH THE COMPLAINT IS NON-VERIFIABLE, A PREVIOUS INVESTIGATION FOUND PEG ENGAGEMENT WITH THE S3 PLATES IS DISCUSSED IN (B)(4) AND (B)(4) AND IS APPROVED WITH AN IFR (INVESTIGATE FURTHER REDUCTION) DESIGNATION. PREVIOUS INVESTIGATIONS DETERMINED THAT PEG 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. (B)(4) WAS OPENED ON (B)(4) 2011 TO FURTHER INVESTIGATE CAUSES OF THE PEG ENGAGEMENT ISSUES AND TO DETERMINE IF ANY ADDITIONAL ACTIONS MAY DECREASE THE LIKELIHOOD OF PEG ENGAGEMENT ISSUES. KNOWN ROOT CAUSES OF PEG ENGAGEMENT ISSUES ARE PATIENT ANATOMY AND SURGICAL TECHNIQUE. (B)(4) WILL FURTHER INVESTIGATE IF THERE ARE ADDITIONAL ROOT CAUSES THAT CAN BE MITIGATED. 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.

    Description of Event or Problem · 1

    PT WAS REVISED DUE TO SCREWS BACKING OUT OF S3 SHOULDER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN S3 SHOULDER PLATE TRUAM SCREWS HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention