BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 5947808 · Received September 13, 2016

    Report

    Report Number
    0002249697-2016-02929
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    August 21, 2012
    Report Date
    August 17, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K110533
    Removal / Correction Number
    2249697-11/19/12-013-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A SLOPED TIBIAL TRAY INVOLVING A US SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS:-DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED.-MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: A SEARCH OF THE SUPER AND CHS COMPLAINT DATABASES INDICATES THAT SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. VOLUNTARY HOLD (B)(4) AND VOLUNTARY RECALL RA 2012-171 WERE ISSUED. CONCLUSIONS THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS X-RAY IMAGES, RECENT CLINICAL FOLLOW UP AND CONFIRMATION OF PATIENTS COMPLAINT OF DISLOCATION ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THIS EVENT BECAME A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PLAINTIFF UNDERWENT A TOTAL KNEE REPLACEMENT PERFORMED WITH A STRYKER SHAPEMATCH GUTTING GUIDE AND TRIATHLON KNEE ON OR ABOUT (B)(6) 2012. PLAINTIFF ALLEGES THAT THE USE OF THE SHAPEMATCH CUTTING GUIDE RESULTED IN SIGNIFICANT SLOPE OF THE PROXIMAL TIBIA, LEADING TO A POOR OUTCOME RESULTING IN MECHANICAL LOOSENING AND THE NEED FOR A REVISION SURGERY. SUIT FILED IN (B)(4) . REQUIRES REVISION SURGERY (NOT REVISED YET).

    Description of Event or Problem · 1

    PLAINTIFF UNDERWENT A TOTAL KNEE REPLACEMENT PERFORMED WITH A STRYKER SHAPEMATCH GUTTING GUIDE AND TRIATHLON KNEE ON OR ABOUT (B)(6) 2012. PLAINTIFF ALLEGES THAT THE USE OF THE SHAPEMATCH CUTTING GUIDE RESULTED IN SIGNIFICANT SLOPE OF THE PROXIMAL TIBIA, LEADING TO A POOR OUTCOME RESULTING IN MECHANICAL LOOSENING AND THE NEED FOR A REVISION SURGERY. SUIT FILED IN (B)(6). REQUIRES REVISION SURGERY (NOT REVISED YET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599677 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 12167034

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention