BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 3678751 · Received March 14, 2014

    Report

    Report Number
    0002249697-2014-00766
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A DISASSEMBLY ISSUE INVOLVING AN ADM EXPANDABLE COUPLER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: THERE ARE SOME MARKS OF USE ON THE RETURNED DEVICE AND DAMAGES HAVE BEEN DONE WITH AN INSTRUMENT (PINCER) TO REMOVE IT FROM THE CUP AS DESCRIBED BY THE CUSTOMER. A FUNCTIONAL TEST SHOWED THAT THE DEVICE IS WORKING AS EXPECTED, THERE IS NO FUNCTIONAL ISSUE DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE RETURNED DEVICE REFERENCE (B)(4) HAS BEEN DAMAGED WITH AN INSTRUMENT (PINCER) IN ORDER TO REMOVE IT FROM THE CUP. A FUNCTIONAL TEST SHOWED THAT THE DEVICE IS WORKING AS EXPECTED AND THERE IS NO FUNCTIONAL ISSUE. BASED ON THE INFORMATION PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SINCE THE COUPLER WAS NOT ABLE TO BE REMOVED, THE HANDLE WAS REMOVED AT FIRST. SINCE THEN, AFTER DROPPING INTO THE CUP SIDE THE NUT WAS REMOVED BY HOLD THE NECK PART, THE NECK PART WAS DAMAGED.

    Description of Event or Problem · 1

    SINCE THE COUPLER WAS NOT ABLE TO BE REMOVED, THE HANDLE WAS REMOVED AT FIRST. SINCE THEN, AFTER DROPPING INTO THE CUP SIDE THE NUT WAS REMOVED BY HOLD THE NECK PART, THE NECK PART WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153594 RESTORATION ADM MANCHON EXPANS INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3123541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other