BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM DISTAL TAPERED 19X190

    MDR report key: 4148948 · Received October 7, 2014

    Report

    Report Number
    1818910-2014-29529
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK102080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (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

    I WAS INFORMED THAT WHEN THE SURGEON USED THE PROXIMAL REAMER PER PAGE 13 OF THE SURGICAL TECHNIQUE (0612-62-511 VERSION 2 ISSUED: 10/13), THE TAPER PROTECTOR BEGAN TO MELT MAKING IT VERY DIFFICULT TO REMOVE FROM THE STEM CAUSING A MINOR DELAY (LESS THAN 5 MINUTES). THE SURGEON ALSO COMPLAINED THAT EVEN WITHOUT COMPLETING THE PROXIMAL REAMING STEP THE TAPER PROTECTOR IS VERY DIFFICULT TO GET OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627251 RECLAIM DISTAL TAPERED 19X190 HIP FEMORAL STEM/SLEEVE KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1