BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID OFFSET SHELL INSERTER

    MDR report key: 8485419 · Received April 4, 2019

    Report

    Report Number
    0001822565-2019-01414
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Report Date
    July 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE PRODUCT REVEALED THE DEVICE EXHIBITS WEAR & TEAR THAT INDICATES REPEATED USE DURING A POTENTIAL FIELD AGE GREATER THAN 12 YEARS. DAMAGE IS SEEN IN THE CHANNEL OF THE FRAME. THE THREADS OF THE HEX BOLT (00-7804-915-32) ARE CONFORMING TO THREAD GAUGES 25-2003-304-00-AR (GO GAUGE) AND 25-2003-304-01-AR (NOGO GAUGE). THE MAJOR DIAMETER IS ALSO FOUND TO BE CONFORMING TO SPECIFICATIONS. THE DEVICE STILL FUNCTIONS AS INTENDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE DEVICE EVALUATION FOUND NO MALFUNCTION AND THE EVENT DID NOT CONTRIBUTE TO INJURY, THEREFORE THIS WOULD NOT BE CONSIDERED A REPORTABLE EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS INSTRUMENT BROKE. NO KNOWN PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277874 HYBRID OFFSET SHELL INSERTER INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 60561620

    Patients

    Seq Age Sex Outcome Treatment
    1