BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    MDR report key: 5978309 · Received September 26, 2016

    Report

    Report Number
    0001822565-2016-03367
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 30, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK101730
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CONSTRAINED LINER WAS RETURNED FOR REVIEW. VISUAL INSPECTION SHOWS THAT ONE OF THE TWO TABS OF THE LINER HAD FRACTURED OFF AT THE BASE. THE FRACTURED PIECE WAS ALSO RETURNED. THE INNER DOME OF THE LINER SHOWS SIGNS OF REMOVAL DAMAGE. DAMAGE WAS TOO SEVERE FOR DIMENSIONAL ANALYSIS. DEVICE HISTORY RECORD REVIEW IDENTIFIED NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS. THIS DEVICE IS USED FOR TREATMENT. COMPLAINT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS FOR THE PART AND LOT COMBINATION. THE CONSTRAINED LINER WAS CONFIRMED TO BE USED IN A COMPATIBLE COMBINATION WITH A SIMILARLY SIZED BIOLOX HEAD. THE PATIENT HAS A HISTORY OF SUBLUXATION FROM TWO PREVIOUS IMPLANT COMBINATIONS PRIOR TO THE REPORTED EVENT. NO ADDITIONAL RELEVANT MEDICAL HISTORY IS PROVIDED, AND ADHERENCE TO REHABILITATION PROTOCOLS IS UNKNOWN. IT WAS STATED IN THE FOLLOW UP THAT THE LINER WAS DAMAGED DURING INSERTION, AND REMAINED IMPLANTED BEFORE BEING REVISED ON (B)(6) 2016. THEREFORE, THE LIKELY ROOT CAUSE OF THE REPORTED DAMAGE IS ACCIDENTAL MISUSE DURING IMPLANTATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.UPDATED PMA/510K: K101730.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FIXATION RING OF THE CONSTRAINED LINER COULD NOT BE CONNECTED TO THE LINER DUE TO DAMAGE ON ONE LIP OF THE LINER DURING A HIP REVISION. THERE WAS A REPORTED 40 MINUTE DELAY IN PROCEDURE DUE TO THE SURGICAL TEAM ATTEMPTING TO FIX THE RING ON THE LINER. THE SURGEON WAS ABLE TO COMPLETE THE REVISION USING THE DEVICE.

    Description of Event or Problem · 1

    DAMAGED LIP OF THE LINER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629109 HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER HIP PROSTHESIS KWZ ZIMMER, INC. 62362317

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR