BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 2983932 · Received February 28, 2013

    Report

    Report Number
    0002249697-2013-00821
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISASSEMBLY ISSUE INVOLVING AN ADM EXPANDABLE COUPLER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. IT WAS REPORTED THAT WHEN IMPLANTING A 48MM RESTORATION ADM CUP THE CUP BECAME STUCK TO THE EXPANDABLE COUPLER. THE SIZE OF THE CUP AND THE SIZE OF THE EXPANDABLE COUPLER WERE VERIFIED. THE SURGEON HAD TO USE AN INSTRUMENT TO KNOCK THE CUP OFF THE COUPLER. THE CUP WAS THEN PUT INTO PLACE BY HAND AND THE SECONDARY IMPACTOR WAS USED. A REVIEW OF THE SURGICAL PROTOCOL INDICATES THAT FOR EACH CUP DIAMETER (48MM ¿ 64MM) THERE IS A CORRESPONDING EXPANDABLE COUPLER. IN THIS EVENT. THE CATALOG # 1235-4-485 48MM EXPANDABLE COUPLER WAS USED WITH THE CORRECT CUP SIZE. IT IS NOT CLEAR FROM THE EVENT DESCRIPTION WHY THE COUPLER WOULD NOT DISENGAGE WITH THE CUP AND THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS EVENT WITHOUT THE DEVICE BEING AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    WHEN IMPLANTING A 48MM RESTORATION ADM CUP THE CUP BECAME STUCK TO THE EXPANDABLE COUPLER. THE SIZE OF THE CUP AND THE SIZE OF THE EXPANDABLE COUPLER WERE VERIFIED. THE SURGEON HAD TO USE AN INSTRUMENT TO KNOCK THE CUP OFF THE COUPLER. THE CUP WAS THEN PUT INTO PLACE BY HAND AND THE SECONDARY IMPACTOR WAS USED.

    Description of Event or Problem · 1

    WHEN IMPLANTING A 48MM RESTORATION ADM CUP THE CUP BECAME STUCK TO THE EXPANDABLE COUPLER. THE SIZE OF THE CUP AND THE SIZE OF THE EXPANDABLE COUPLER WERE VERIFIED. THE SURGEON HAD TO USE AN INSTRUMENT TO KNOCK THE CUP OFF THE COUPLER. THE CUP WAS THEN PUT INTO PLACE BY HAND AND THE SECONDARY IMPACTOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85634 RESTORATION ADM MANCHON EXPANS INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other