BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3781175 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01691
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 30, 2012
    Report Date
    April 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING AND INSTABILITY INVOLVING A LEFT SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. -COMPLAINT HISTORY REVIEW: SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH A VOLUNTARY HOLD PH2012-122 AND VOLUNTARY RECALL RA 2012-171. CONCLUSIONS VOLUNTARY HOLD PH2012-122 AND VOLUNTARY RECALL RA 2012-171 WERE INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED INSTABILITY IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT KNEE REPLACEMENT IN WHICH A SHAPEMATCH CUTTING GUIDE WAS UTILIZED. IT IS ALLEGED THAT "X-RAYS SHOWED EARLY LOOSENING AS WELL AS INSTABILITY IN PLAINTIFF'S LEFT KNEE." THE PATIENT WAS REVISED ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT KNEE REPLACEMENT IN WHICH A SHAPEMATCH CUTTING GUIDE WAS UTILIZED. IT IS ALLEGED THAT "X-RAYS SHOWED EARLY LOOSENING AS WELL AS INSTABILITY IN PLAINTIFF'S LEFT KNEE." THE PATIENT WAS REVISED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260285 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 11350018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention