BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR-FEM STEM-OFFSET

    MDR report key: 5315805 · Received December 21, 2015

    Report

    Report Number
    3005985723-2015-00311
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    December 3, 2015
    Report Date
    December 3, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: AN EVENT REGARDING CRACK/FRACTURE INVOLVING A IMPACTOR-FEM STEM-OFFSET WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: NO OTHER EVENTS WERE REPORTED FOR THE LOT INDICATED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    OFFSET STEM IMPACTOR TIP BROKE OFF DURING IMPLANT IMPACTION. IMPACTOR TIP LODGED IN THE STEM IN THE SPOT WHERE THE IMPACTOR TIP GOES. SURGEON WAS ABLE TO REMOVE THE TIP FROM THE STEM. THE TIP WAS NOT LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    OFFSET STEM IMPACTOR TIP BROKE OFF DURING IMPLANT IMPACTION. IMPACTOR TIP LODGED IN THE STEM IN THE SPOT WHERE THE IMPACTOR TIP GOES. SURGEON WAS ABLE TO REMOVE THE TIP FROM THE STEM. THE TIP WAS NOT LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841974 IMPACTOR-FEM STEM-OFFSET HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG MAKO SURGICAL CORP. 120170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other