BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE LINR- E-POLY HIGH-36/54 IMPLANT

    MDR report key: 4765170 · Received May 12, 2015

    Report

    Report Number
    3005985723-2015-00073
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO REPORTED IN THIS REPORT: ACE SHELL- CLUST HOLE POR-54MM IMPLANT; CAT# 186002-54; LOT# 031146-01; ACE BONE SCREW- 6.5 DIA-30MM IMPLANT; CAT# 186005-30; LOT# 170069-01; ACE BONE SCREW- 6.5 DIA-25MM IMPLANT; CAT# 186005-25; LOT# 170049-01. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT TO PATHOLOGY AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE REPORTED LOT CODE DETERMINED THE DEVICE WAS MANUFACTURED ON 31-JUL-2013. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    I RECEIVED A PHONE CALL FROM DR. (B)(6) CALLED TELLING ME THAT HE WANTED TO REMOVE A ACETABULAR LINER AND FEMORAL HEAD FROM A PATIENT WHO HAD HER PRIMARY SURGERY ABOUT 3 WEEKS AGO DUE TO INFECTION.

    Description of Event or Problem · 1

    I RECEIVED A PHONE CALL FROM DR. (B)(6) CALLED TELLING ME THAT HE WANTED TO REMOVE A ACETABULAR LINER AND FEMORAL HEAD FROM A PATIENT WHO HAD HER PRIMARY SURGERY ABOUT 3 WEEKS AGO DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308730 ACE LINR- E-POLY HIGH-36/54 IMPLANT IMPLANT OQG MAKO SURGICAL CORP. 190513-01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention