BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE LINR-NEUT-40X58/60 RESTORIS XLVE

    MDR report key: 6094509 · Received November 10, 2016

    Report

    Report Number
    3005985723-2016-00378
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    November 7, 2016
    Report Date
    March 27, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. AN EVENT REGARDING DISASSOCIATION INVOLVING AN ACE LINR-NEUT-40X58/60 RESTORIS XLVE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND 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 EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TOTAL HIP ARTHROPLASTY WHEN ONCE FINAL IMPLANTS WERE IN DURING FINAL REDUCTION THE LINER 58-60MM X 40 DISENGAGED FROM THE CUP. CUP WAS PROPERLY PLACED AND STAYED IN PLACE. NO DELAY IN THE SURGERY JUST OPENED ANOTHER LINER

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A TOTAL HIP ARTHROPLASTY WHEN ONCE FINAL IMPLANTS WERE IN DURING FINAL REDUCTION THE LINER 58-60MM X 40 DISENGAGED FROM THE CUP. CUP WAS PROPERLY PLACED AND STAYED IN PLACE. NO DELAY IN THE SURGERY JUST OPENED ANOTHER LINER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743202 ACE LINR-NEUT-40X58/60 RESTORIS XLVE HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG MAKO SURGICAL CORP. LOT# 190636-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other