BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY

    MDR report key: 3915328 · Received July 7, 2014

    Report

    Report Number
    0002249697-2014-02557
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 13, 2012
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MISALIGNED COMPONENTS INVOLVING A LEFT SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. 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 MISALIGNED COMPONENTS EVENT 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 ON (B)(6) 2012, PATIENT HAD HER KNEE REPLACED WITH THE USE OF A STRYKER SHAPEMATCH CUTTING GUIDE. SUBSEQUENT TO HER KNEE REPLACEMENT, PLAINTIFF BEGAN EXPERIENCING SIGNIFICANT KNEE PAIN AND DISCOMFORT AND JOINT INSTABILITY AND LIMITED ON MOBILITY. DIAGNOSTIC TESTING HAS REVEALED THAT THE KNEE REPLACEMENT IS MISALIGNED AND NEEDS TO BE REPLACED BUT THE DAMAGE IS SO EXTENSIVE THAT EVEN THOUGH THE KNEE NEEDS TO BE REPLACED, IT IS IMPOSSIBLE TO DO SO.

    Description of Event or Problem · 1

    IT WAS REPORTED ON JUNE 13, 2012, PATIENT HAD HER KNEE REPLACED WITH THE USE OF A STRYKER SHAPEMATCH CUTTING GUIDE. SUBSEQUENT TO HER KNEE REPLACEMENT, PLAINTIFF BEGAN EXPERIENCING SIGNIFICANT KNEE PAIN AND DISCOMFORT AND JOINT INSTABILITY AND LIMITED ON MOBILITY. DIAGNOSTIC TESTING HAS REVEALED THAT THE KNEE REPLACEMENT IS MISALIGNED AND NEEDS TO BE REPLACED BUT THE DAMAGE IS SO EXTENSIVE THAT EVEN THOUGH THE KNEE NEEDS TO BE REPLACED, IT IS IMPOSSIBLE TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394704 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON LEFT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12124011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other