BEUDAMED
    FDA Adverse Event Other Summary report: N

    TACTILE GUIDANCE SYSTEM

    MDR report key: 1173484 · Received September 19, 2008

    Report

    Report Number
    3005985723-2008-00006
    Event Type
    Other
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 20, 2008
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    HAW
    PMA / PMN Number
    K072806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT WAS ASSOCIATED WITH AN IMPLANT SYSTEM THAT IS MANUFACTURED BY MEDICAL DEVICE COMPANY, STELKAST, AND DISTRIBUTED BY (B) (4) FOR USE WITH THE TGS. THERE IS NO INDICATION THAT THE TGS CONTRIBUTED TO THE ROOT CAUSE OF THE FAILURE OF THE IMPLANT. A COMPLAINT HAS BEEN FILED WITH THE MANUFACTURER AND THE EXPLANTED DEVICE HAS BEEN RETURNED FOR EVALUATION. (B) (4) IS FILING THIS MDR TO ENSURE VISIBILITY TO A REVISION THAT OCCURRED AS A RESULT OF A PROCEDURE THAT UTILIZED A TGS. NO EVALUATION WAS EXECUTED ON THE TGS INVOLVED; INDICATIONS ARE THE SYSTEM PERFORMED SAFELY AND EFFECTIVELY.

    Description of Event or Problem · 1

    THE PATIENT'S ORIGINAL MAKOPLASTY WAS PERFORMED ON (B) (6) 2008. THE PATIENT WAS SEEN BY THE SURGEON FOR PAIN IN HER KNEE. THE CAUSE WAS IDENTIFIED BY THE SURGEON AS MICROMOTION OF THE TIBIA. AFTER EXPLANTING THE STELKAST TIBIAL INLAY COMPONENT, THE SURGEON INDICATED IT WAS "PERFECT - NO OBVIOUS DEFORMITIES." "[THE IMPLANT HAD] PERFECT INTEGRATION OF THE CEMENT INTO THE BONE - FAILURE WAS DEBONDING OF THE POLY FROM THE UNDER SURFACE OF THE POLY TO THE CEMENT. ALIGNMENT OF THE FEMUR TO THE TIBIA WAS PERFECT." - DOCUMENTED IN COMPLAINT FILE. STELKAST INLAY TIBIA WAS REPLACED WITH A DEPUY SIGMA SIZE 3X9MM ONLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACTILE GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT HAW MAKO SURGICAL CORP. 0040TAS00000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention STELKAST UNI-KNEE SYSTEM