BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALAMEDA DESIGNED ITEM PRIOR TO SYK PURCHASE

    MDR report key: 3948942 · Received July 22, 2014

    Report

    Report Number
    0002249697-2014-02809
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 15, 2009
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE IS "ALAMEDA DESIGNED ITEM PRIOR TO SYK PURCHASE" AND IT WAS USED DURING PRIMARY SURGERY ON (B)(6) 2008 PRIOR TO ACQUISITION OF ALAMEDA BY STRYKER.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: ¿THE PI AS SUBMITTED DOES NOT APPEAR TO BE RELATED TO THE USE OF SHAPE MATCH CUTTING GUIDES OR THE TRIATHLON IMPLANT. WHILE THIS CASE WAS WITHIN THE SCOPE OF PRODUCT RECALL REGULATORY ACTION 2012-171, THIS PI WAS NOT FELT TO BE RELATED TO THE SHAPEMATCH CUTTING JIGS. INSTABILITY EXPERIENCED BY THE PATIENT WAS FELT RELATED TO LIGAMENT INSUFFICIENCY.¿ A CLINICIAN CONSULTANT HAS REVIEWED THE PROVIDED INFORMATION AND HAS INDICATED THAT "THE PI AS SUBMITTED DOES NOT APPEAR TO BE RELATED TO THE USE OF SHAPE MATCH CUTTING GUIDES OR THE TRIATHLON IMPLANT. INSTABILITY EXPERIENCED BY THE PATIENT WAS FELT RELATED TO LIGAMENT INSUFFICIENCY.¿ THERE IS NO INDICATION AT THIS TIME THAT THE DESIGN, MATERIALS, OR MANUFACTURING OF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAD SEVERE PAIN, INSTABILITY, CUTTING GUIDES WERE INCORRECTLY MEASURED AND THE CUTS WERE WRONG. PATIENT STATES THAT THE CUSTOM CUTTING GUIDES USED TO BE CALLED OTIS MED AND ARE NOW CALLED SHAPE MATCH TECH. PATIENT HAD REVISION SURGERY ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE PATIENT HAD SEVERE PAIN, INSTABILITY, CUTTING GUIDES WERE INCORRECTLY MEASURED AND THE CUTS WERE WRONG. PATIENT STATES THAT THE CUSTOM CUTTING GUIDES USED TO BE CALLED OTIS MED AND ARE NOW CALLED SHAPE MATCH TECH. PATIENT HAD REVISION SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428181 ALAMEDA DESIGNED ITEM PRIOR TO SYK PURCHASE INSTRUMENT MEH STRYKER ORTHOPAEDICS-MAHWAH LIP128-B4574

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention