BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 5000393 · Received August 13, 2015

    Report

    Report Number
    0002249697-2015-02627
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K110533
    Removal / Correction Number
    2249697-11/19/12-013-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION. AN EVENT REGARDING REVISION INVOLVING A RIGHT SHAPEMATCH CUTTING GUIDE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. 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 REVISION IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DOCTOR THAT MR. (B)(6) ALLEGEDLY UNDERWENT A KNEE ARTHROPLASTY WHERE STRYKER SHAPEMATCH CUTTING GUIDES WERE USED. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT A REVISION. PATIENT ALLEGES THAT THE REVISION WAS DUE TO SHAPEMATCH USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DOCTOR THAT (B)(6) ALLEGEDLY UNDERWENT A KNEE ARTHROPLASTY WHERE STRYKER SHAPEMATCH CUTTING GUIDES WERE USED. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT A REVISION. PATIENT ALLEGES THAT THE REVISION WAS DUE TO SHAPEMATCH USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536646 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH 12144027

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention