BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 3678746 · Received March 14, 2014

    Report

    Report Number
    0002249697-2014-00767
    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

    AN EVENT REGARDING DAMGE INVOLVING AN ADM EXPANDABLE COUPLER WAS REPORTED. THE EVENT WAS CONFIRMED. -DEVICE EVALUATION AND RESULTS: A FUNCTIONAL TEST SHOWED THAT THE DEVICE IS WORKING AS EXPECTED, THERE IS NO FUNCTIONAL ISSUE. THIS DEFORMATION IS NORMAL AS DURING USE THE COUPLER IS EXPANDED INSIDE THE CUP. -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 1235-4-645 HAS BEEN USED AND IS SLIGHTLY DEFORMED. A FUNCTIONAL TEST SHOWED THAT THE DEVICE IS WORKING AS EXPECTED, THERE IS NO FUNCTIONAL ISSUE. THIS DEFORMATION IS NORMAL AS DURING USE THE COUPLER IS EXPANDED INSIDE THE CUP. BASED ON THE INFORMATION PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WHEN CHECKING THE RETURNED PRODUCT DEFORMATION OF THE TIP OF THE COUPLER WAS OBSERVED. BUT IT WAS NOT USED AT THE OPERATION.

    Description of Event or Problem · 1

    WHEN CHECKING THE RETURNED PRODUCT DEFORMATION OF THE TIP OF THE COUPLER WAS OBSERVED. BUT IT WAS NOT USED AT THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153000 RESTORATION ADM MANCHON EXPANS INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3132635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other