BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORATION ADM MANCHON EXPANS

    MDR report key: 3523584 · Received December 17, 2013

    Report

    Report Number
    0002249697-2013-04079
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    E207315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ALLEGED DIFFICULTY DISASSEMBLING A TRIAL CUP FROM THE CUP IMPACTOR ASSEMBLY WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED. THE EVENT DESCRIPTION STATED THAT WHEN THE INSTRUMENTAL WAS ASSEMBLED, THEY NOTICED THAT THEY COULD NOT FIX THE TRIAL CUP TO THE ADAPTER. WHEN THEY MANAGED TO FIX IT, THEY COULD NOT SEPARATE THE ADAPTER FROM THE TRIAL CUP, SO THEY DECIDE NOT TO USE THE INSTRUMENTAL AND THE DEFINITIVE CUP WAS IMPLANTED MANUALLY. A REVIEW OF THE REPORTED EVENT BY THE SUPPLIER CONCLUDED THAT THE EVENT DESCRIPTION IS NOT CLEAR BECAUSE THE CUSTOMER IS TRYING TO FIX THE TRIAL CUP TO THE CUP IMPACTOR ASSEMBLY. BUT THE TRIAL CUP IS USED WITH A TRIAL CUP HOLDER, NOT THE REPORTED DEVICES (AS EXPLAINED IN THE SURGICAL TECHNIQUE). NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING IMPROPER USE OF AN INSTRUMENT INVOLVING AN ADM CUP IMPACTOR ASSEMBLY WAS REPORTED. CONCLUSION: THE RETURNED DEVICE WAS INSPECTED AND FOUND TO BE FULLY FUNCTIONAL. THE REPORTED EVENT INDICATED THAT AN ADM TRIAL CUP COULD NOT BE ASSEMBLED AND DISASSEMBLED TO AN ADM CUP IMPACTOR ASSEMBLY. THE ADM SURGICAL PROTOCOL INDICATES THAT A SEPARATE INSTRUMENT EXISTS FOR USE WITH THE TRIAL CUP, AND THAT THE SUBJECT CUP IMPACTOR ASSEMBLY IS FOR USE WITH THE DEFINITIVE IMPLANT ONLY. BASED ON THE INFORMATION REVIEWED THE REPORTED EVENT CONSTITUTES OFF LABEL USE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD PROBLEMS WITH THE DEVICE: THE SURGICAL TECHNIQUE WAS FOLLOWED BUT WHEN THE INSTRUMENT WAS ASSEMBLED, THEY NOTICED THAT THEY COULD NOT FIX THE TRIAL CUP TO THE ADAPTER. WHEN THEY MANAGED TO FIX IT, THEY COULD NOT SEPARATE THE ADAPTER FROM THE TRIAL CUP, SO THEY DECIDE NOT TO USE THE INSTRUMENT AND THE DEFINITIVE CUP WAS IMPLANTED MANUALLY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD PROBLEMS WITH THE DEVICE: THE SURGICAL TECHNIQUE WAS FOLLOWED BUT WHEN THE INSTRUMENT WAS ASSEMBLED, THEY NOTICED THAT THEY COULD NOT FIX THE TRIAL CUP TO THE ADAPTER. WHEN THEY MANAGED TO FIX IT, THEY COULD NOT SEPARATE THE ADAPTER FROM THE TRIAL CUP, SO THEY DECIDE NOT TO USE THE INSTRUMENT AND THE DEFINITIVE CUP WAS IMPLANTED MANUALLY.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD PROBLEMS WITH THE DEVICE: THE SURGICAL TECHNIQUE WAS FOLLOWED BUT WHEN THE INSTRUMENT WAS ASSEMBLED, THEY NOTICED THAT THEY COULD NOT FIX THE TRIAL CUP TO THE ADAPTER. WHEN THEY MANAGED TO FIX IT, THEY COULD NOT SEPARATE THE ADAPTER FROM THE TRIAL CUP, SO THEY DECIDE NOT TO USE THE INSTRUMENT AND THE DEFINITIVE CUP WAS IMPLANTED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659830 RESTORATION ADM MANCHON EXPANS INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3051753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other