BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA PLI XLK INS 4 8MM

    MDR report key: 7593279 · Received June 12, 2018

    Report

    Report Number
    1818910-2018-61965
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 16, 2018
    Report Date
    May 16, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US 1818910
    Product Code
    JWH
    UDI-DI
    10603295062660
    PMA / PMN Number
    K040166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEVICE HISTORY LOT: PRODUCT CODE 158104108, LOT NUMBER 8250465. DEVICE HISTORY REVIEW: 24 PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO NCS OR DEVIATIONS ASSOCIATED WITH THIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DER STATES DURING A LEFT TOTAL KNEE, AND INSERTION AND IMPACTION OF AN INSERT, ONE OF THE ANTERIOR LOCKING MECHANISMS BROKE. THE REP HAD ANOTHER ONE ON-SITE AND THAT ONE WENT IN NO PROBLEM. NO PIECES CAME DETACHED FROM THE INSERT AND THERE WAS NOTHING LEFT IN THE PATIENT TO RETRIEVE. SURGEON FEELS HE DIDN'T HAVE THE INSERT POSTERIORLY ENOUGH AND WHEN HE IMPACTED IT THE LOCKING TAB WAS DAMAGED. DOE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435402 SIGMA PLI XLK INS 4 8MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US 1818910 8250465 10603295062660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR