BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL HEAD - 24MM

    MDR report key: 8601829 · Received May 10, 2019

    Report

    Report Number
    1651501-2019-00017
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 11, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    KWI
    PMA / PMN Number
    K032806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE DHR FOR PN: 221424, LOT: KV0101 WAS REVIEWED. THE LOT SIZE WAS 111 UNITS. RECORDS SHOWS THAT A SAMPLE OF 20 PARTS UNDERWENT DIMENSIONAL INSPECTION, ALL OF WHICH WERE WITHIN SPECIFICATION. NO NONCONFORMANCES WERE GENERATED ASSOCIATED WITH THIS LOT. POSSIBLE ROOT CAUSE INCLUDE USER ERROR (MISMATCH BETWEEN STEM AND HEAD SIZING), DAMAGE INDUCED DURING SURGERY, OR USER INTERFACE. HOWEVER, BASED ON THE INFORMATION TO DATE, THE ROOT CAUSE FOR THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE COUPLING OF THE KATALYST RADIAL HEAD (PN: 221424, LOT: KV0101) AND STEM INTRA-OPERATIVELY ON (B)(6) 2019, THE POLY ON THE IMPLANT INITIALLY GAVE GREATER RESISTANCE TO COUPLING THAN IS CUSTOMARY. AFTER MULTIPLE ATTEMPTS TO COUPLE THE IMPLANTS, THIS IMPLANT FINALLY COUPLED WITH THE STEM, BUT DID NOT HAVE THE AUDIBLE POPPING SOUND THAT IS USUALLY HEARD BY THE SURGEON AND WAS USED AS AN INDICATION THAT THE INTERFACE INTERACTED AS EXPECTED. THE SURGEON SUSPECTED THAT THIS MAY INDICATE THAT THE TOLERANCES OF THE POLY WERE NOT AS DESIGNED. THIS ITEM WAS REMOVED FROM THE PATIENT AND ANOTHER IMPLANT WITH A DIFFERENT LOT NUMBER WAS IMPLANTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392035 RADIAL HEAD - 24MM KWI INTEGRA LIFESCIENCES CORPORATION OH/USA KV0101

    Patients

    Seq Age Sex Outcome Treatment
    1