BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 4215920 · Received October 30, 2014

    Report

    Report Number
    0002249697-2014-04069
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 7, 2012
    Report Date
    October 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K110533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN, INABILITY TO BEND THE KNEE, SWELLING, AND DISCOLORATION INVOLVING A 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. -DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. -COMPLAINT HISTORY REVIEW: A SEARCH OF THE COMPLAINT DATABASES INDICATED THAT SIMILAR EVENTS HAVE OCCURRED FOR THE US SHAPEMATCH CUTTING GUIDES. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH A VOLUNTARY HOLD AND VOLUNTARY RECALL RA 2012-171. CONCLUSIONS VOLUNTARY HOLD AND VOLUNTARY RECALL RA 2012-171 WERE INITIATED FOR US SHAPEMATCH CUTTING GUIDES DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED INABILITY TO BEND THE KNEE IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    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 AFTER USAGE OF THE SHAPE MATCH SYSTEM TO IMPLANT PLAINTIFFS' RIGHT KNEE, SHE BEGAN EXPERIENCING SIGNIFICANT PAIN, WAS UNABLE TO BEND HER RIGHT KNEE, AND HAD PRONOUNCED SWELLING AND DISCOLORATION DEVELOP IN THE AREA OF THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT MANIPULATIVE PROCEDURE TWELVE WEEKS AFTER THE ORIGINAL PROCEDURE, BUT THE MANIPULATIVE PROCEDURE DID NOT RELIEVE HER SYMPTOMS. SHE ALLEGEDLY UNDERWENT A RIGHT KNEE REVISION SURGERY IN (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY AFTER USAGE OF THE SHAPE MATCH SYSTEM TO IMPLANT PLAINTIFFS' RIGHT KNEE, SHE BEGAN EXPERIENCING SIGNIFICANT PAIN, WAS UNABLE TO BEND HER RIGHT KNEE, AND HAD PRONOUNCED SWELLING AND DISCOLORATION DEVELOP IN THE AREA OF THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT MANIPULATIVE PROCEDURE TWELVE WEEKS AFTER THE ORIGINAL PROCEDURE, BUT THE MANIPULATIVE PROCEDURE DID NOT RELIEVE HER SYMPTOMS. SHE ALLEGEDLY UNDERWENT A RIGHT KNEE REVISION SURGERY IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695282 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH 12233008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention