BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS FEM TO SLEEVE ADAPTER +5

    MDR report key: 3091942 · Received May 3, 2013

    Report

    Report Number
    1818910-2013-16514
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK071417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED; HOWEVER, THE INVESTIGATION CONFIRMED THE REPORTED INABILITY TO EXTRACT THE SLEEVE ADAPTER. THE ROOT CAUSE IS DESIGN RELATED. VIA (B)(4) THE PRODUCT DESIGN HAS BEEN IMPROVED TO ALLOW EXTRACTION OF THE LPS FEM TO SLEEVE ADAPTER. NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE REPORTED CONCERN. THE ROOT CAUSE IS DESIGN RELATED. VIA (B)(4) THE PRODUCT DESIGN HAS BEEN IMPROVED TO ALLOW EXTRACTION OF THE LPS FEM TO SLEEVE ADAPTER. NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. DURING THE FIRST ATTEMPT AT REVISION, ON (B)(6) 2013, THE SURGEON COMPLAINED ABOUT THERE BEING NO EXTRACTOR FOR THE SLEEVE ADAPTER; THE THREADS ARE ON THE WRONG SIDE, COLD-WELDS, AND IS VERY DIFFICULT TO EXTRACT. THE SURGERY WAS UNSUCCESSFUL AND HAD TO BE REATTEMPTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194910 LPS FEM TO SLEEVE ADAPTER +5 KNEE PROSTHESIS MBH 1818910 DEPUY ORTHOPAEDICS, INC. FN3HY1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention