BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECLAIM DISTAL TAPERED 24X190A

    MDR report key: 4148896 · Received October 7, 2014

    Report

    Report Number
    1818910-2014-29532
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK102080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON WANTED TO REMOVE PLASTIC SLEEVE BEFORE INSERTION. THE PLASTIC SLEEVE WAS STUCK ON THE STEM. AFTER SEVERAL ATTEMPTS, THE SEAL WAS BROKEN. THIS CAUSED A 20 MINUTE DELAY IN SURGERY. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SURGEON WANTED TO REMOVE PLASTIC SLEEVE BEFORE INSERTION. THE PLASTIC SLEEVE WAS STUCK ON THE STEM. AFTER SEVERAL ATTEMPTS, THE SEAL WAS BROKEN. THIS CAUSED A 20 MINUTE DELAY IN SURGERY. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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.

    Description of Event or Problem · 1

    SURGEON WANTED TO REMOVE PLASTIC SLEEVE BEFORE INSERTION. THE PLASTIC SLEEVE WAS STUCK ON THE STEM. AFTER SEVERAL ATTEMPTS, THE SEAL WAS BROKEN. THIS CAUSED A 20 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626928 RECLAIM DISTAL TAPERED 24X190A HIP FEMORAL STEM/SLEEVE KWA 1818910 DEPUY ORTHOPAEDICS, INC. 108376

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR