BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM TAPER PROTECTOR SLEEVE

    MDR report key: 4149817 · Received October 7, 2014

    Report

    Report Number
    1818910-2014-29530
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TAPER PROTECTOR SLEEVE WAS OPENED AND USED ON THE STEM, BUT WAS LATER DIFFICULT TO REMOVE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. DEPUY ORTHOPAEDICS, INC. ISSUED A VOLUNTARY DEVICE CORRECTION OF ALL LOTS OF THE RECLAIM® TAPER SLEEVE PROTECTOR INSTRUMENT BECAUSE THE PRODUCT CAN BE DIFFICULT TO REMOVE FROM THE DISTAL STEM BOTH BEFORE SURGERY AND AFTER PROXIMAL REAMING. THE IMMEDIATE REMEDY IS FOR ALL USERS TO DISCARD THE AFFECTED TAPER SLEEVE PROTECTOR PRIOR TO STEM IMPLANTATION. NO FURTHER CORRECTIVE ACTION IS FOUND NECESSARY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODE REQUIRED WAS NOT PROVIDED. DEPUY ORTHOPAEDICS, INC. ISSUED A VOLUNTARY DEVICE CORRECTION OF ALL LOTS OF THE RECLAIM® TAPER SLEEVE PROTECTOR INSTRUMENT BECAUSE THE PRODUCT CAN BE DIFFICULT TO REMOVE FROM THE DISTAL STEM BOTH BEFORE SURGERY AND AFTER PROXIMAL REAMING. THE IMMEDIATE REMEDY IS FOR ALL USERS TO DISCARD THE AFFECTED TAPER SLEEVE PROTECTOR PRIOR TO STEM IMPLANTATION. NO FURTHER CORRECTIVE ACTION IS FOUND NECESSARY. MONITOR VIA SEP-419. 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

    TAPER PROTECTOR SLEEVE WAS OPENED AND USED ON THE STEM, BUT WAS LATER DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629367 RECLAIM TAPER PROTECTOR SLEEVE HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1