BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 3676553 · Received March 13, 2014

    Report

    Report Number
    0002249697-2014-00762
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    November 16, 2011
    Report Date
    February 19, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING INSTABILITY INVOLVING A RIGHT 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 (B)(4) AND VOLUNTARY RECALL RA 2012-171. CONCLUSIONS VOLUNTARY HOLD (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT A KNEE REPLACEMENT USING A STRYKER TRIATHLON KNEE AND THAT DURING THE PROCEDURE THE SURGEON USED THE SHAPEMATCH CUTTING GUIDE. IT IS FURTHER ALLEGED "SUBSEQUENT TO THE SURGERY, THE PATIENT EXPERIENCED SEVERE INSTABILITY, FAILURE OF THEIR PROSTHESIS AND REVISION SURGERY." IT IS FURTHER ALLEGED THAT THE "CUTTING GUIDES DID NOT MEET THE SURGEON'S PRE-OPERATIVE PLANNING PARAMETERS ENTERED VIA THE WEB APPLICATION."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT A KNEE REPLACEMENT USING A STRYKER TRIATHLON KNEE AND THAT DURING THE PROCEDURE THE SURGEON USED THE SHAPEMATCH CUTTING GUIDE. IT IS FURTHER ALLEGED "SUBSEQUENT TO THE SURGERY, THE PATIENT EXPERIENCED SEVERE INSTABILITY, FAILURE OF THEIR PROSTHESIS AND REVISION SURGERY." IT IS FURTHER ALLEGED THAT THE "CUTTING GUIDES DID NOT MEET THE SURGEON'S PRE-OPERATIVE PLANNING PARAMETERS ENTERED VIA THE WEB APPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151390 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 11278014

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention