BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY

    MDR report key: 4965593 · Received August 4, 2015

    Report

    Report Number
    0002249697-2015-02557
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    April 17, 2013
    Report Date
    July 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN INVOLVING A US 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. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS INDICATES THAT THIS DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A SEARCH OF THE SUPER AND CHS COMPLAINT DATABASES INDICATED OTHER 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: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. 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. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT MW5041464 REPORTED: VOLUN 18-MAR-2015: I HAD THE SHAPE MATCH TRIATHLON GET AROUND KNEE PUT IN ON MY RIGHT KNEE AFTER THE SYMPTOMS DID NOT IMPROVE SO I ENDED UP HAVING A REVISION DONE TO THE RIGHT KNEE. THE HEALING PROCESS AND MORE X-RAYS WERE TAKEN; IT WAS SHOWN THAT THE ORIGINAL CUTS TO MY RIGHT KNEE WERE WRONG. I WAS PUT THROUGH THE MRI PROCESS AND THE IMAGES WERE SENT TO STRYKER SO THEY COULD BUILD THE TOOL AND THE KNEE TO EXACTLY FIT MY KNEE, BUT I CONTINUED TO GET WORSE. I WAS FALLING AND HAVING PAIN AND SWELLING. IT DID NOT FIX THE PROBLEM. WHEN THE REVISION WAS DONE IT HELPED FOR ABOUT A MONTH THEN THE SYMPTOMS CAME BACK ALONG WITH INSTABILITY; THE FALLING AND PAIN HAD INCREASED.

    Description of Event or Problem · 1

    MAUDE EVENT REPORT MW5041464 REPORTED: VOLUN 18-MAR-2015: I HAD THE SHAPE MATCH TRIATHLON GET AROUND KNEE PUT IN ON MY RIGHT KNEE AFTER THE SYMPTOMS DID NOT IMPROVE SO I ENDED UP HAVING A REVISION DONE TO THE RIGHT KNEE. THE HEALING PROCESS AND MORE X-RAYS WERE TAKEN; IT WAS SHOWN THAT THE ORIGINAL CUTS TO MY RIGHT KNEE WERE WRONG. I WAS PUT THROUGH THE MRI PROCESS AND THE IMAGES WERE SENT TO STRYKER SO THEY COULD BUILD THE TOOL AND THE KNEE TO EXACTLY FIT MY KNEE, BUT I CONTINUED TO GET WORSE. I WAS FALLING AND HAVING PAIN AND SWELLING. IT DID NOT FIX THE PROBLEM. WHEN THE REVISION WAS DONE IT HELPED FOR ABOUT A MONTH THEN THE SYMPTOMS CAME BACK ALONG WITH INSTABILITY; THE FALLING AND PAIN HAD INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508484 PATIENT SPECIFIC CUTTING GUIDE - TRIATHLON RIGHT - US ONLY INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH 12199020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention