BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #2 11MM

    MDR report key: 6363138 · Received February 27, 2017

    Report

    Report Number
    0002249697-2017-00690
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    October 1, 2012
    Report Date
    May 25, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TRIATHLON CR FEM COMP #2 L-CEM; CAT # 5510-F-201; LOT# SY4AM; TRI TS BASEPLATE SIZE 2; CAT # 5521-B-200; LOT# BDMU; TRIATHLON SYMMETRIC X3 PATELLA; CAT # 5550-G-298; LOT# 6AE2. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 AND LOOSENING INVOLVING AN TRIATHLON INSERT WAS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT. THE INSERT IS AN INTEGRAL PART OF THE TIBIAL COMPONENT CONSTRUCT AND WILL HAVE TO BE EXPLANTED TOGETHER WITH THE LOOSE BASEPLATE. LOOSENING OF THE FEMORAL COMPONENT, PATELLA AND BASEPLATE COULD NOT BE CONFIRMED. NO OTHER ALLEGATIONS WERE MADE AGAINST THE INSERT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    MAUDE REPORT : SUS VOLUNTARY EVENT REPORT (5066918). SLIPPED AND FELL AT WORK. (B)(6) DENIED MRI, 2 MONTHS LATER APPROVED A SCOPE WHERE CLASS 3 TEARS WERE FOUND IN THE CARTILAGE AND REMOVED CAUSING BONE ON BONE WARE. EVENTUALLY THEY APPROVED THE LEFT KNEE ARTHROPLASTY USING THE STRYKER TRIATHLON. IMMEDIATELY, IT FELT AS IF L WAS ON A BIND. I ALERTED THE DOCTOR WHO SAID IT MAY BE NORMAL, I HAVE HAD TROUBLE EVER SINCE. I CONTINUED SEEING THE DOCTOR AND EVEN GETTING SECOND AND THIRD OPINIONS WHOM REQUESTED REVISION. I HAVE SINCE EXPERIENCED WORSENING NERVE DAMAGE, LESS AND LESS MOBILITY INCLUDING PAIN 24/7 TO BE DENIED ANY MORE PROCEDURES THROUGH (B)(6) EVEN AFTER DOCTOR'S REQUESTS TO REVISE KNEE. I WAS NEVER TOLD OF A SOFTWARE RECALL OF THE SHAPEMATCH CUTTING GUIDES. I CAME ACROSS IT WHILE DOING RESEARCH ON SYMPTOMS. I HAVE RECEIVED THE OPERATIVE NOTES FROM MY DOCTOR WITH THE BAR CODES AND WAITING FOR THE HOSPITAL NOTES WITH THE SOFTWARE USED. (B)(6) IS STILL DENYING MY REVISION PER DOCTOR'S ORDER FDA CLASS 1 RECALL NOTICE.

    Description of Event or Problem · 1

    MAUDE REPORT : SUS VOLUNTARY EVENT REPORT (5066918). SLIPPED AND FELL AT WORK. WORKMAN COMP DENIED MRI, 2 MONTHS LATER APPROVED A SCOPE WHERE CLASS 3 TEARS WERE FOUND IN THE CARTILAGE AND REMOVED CAUSING BONE ON BONE WARE. EVENTUALLY THEY APPROVED THE LEFT KNEE ARTHROPLASTY USING THE STRYKER TRIATHLON. IMMEDIATELY, IT FELT AS IF L WAS ON A BIND. I ALERTED THE DOCTOR WHO SAID IT MAY BE NORMAL, I HAVE HAD TROUBLE EVER SINCE. I CONTINUED SEEING THE DOCTOR AND EVEN GETTING SECOND AND THIRD OPINIONS WHOM REQUESTED REVISION. I HAVE SINCE EXPERIENCED WORSENING NERVE DAMAGE, LESS AND LESS MOBILITY INCLUDING PAIN 24/7 TO BE DENIED ANY MORE PROCEDURES THROUGH WORKMAN'S COMP EVEN AFTER DOCTOR'S REQUESTS TO REVISE KNEE. I WAS NEVER TOLD OF A SOFTWARE RECALL OF THE SHAPEMATCH CUTTING GUIDES. I CAME ACROSS IT WHILE DOING RESEARCH ON SYMPTOMS. I HAVE RECEIVED THE OPERATIVE NOTES FROM MY DOCTOR WITH THE BAR CODES AND WAITING FOR THE HOSPITAL NOTES WITH THE SOFTWARE USED. WORKMAN'S COMP IS STILL DENYING MY REVISION PER DOCTOR'S ORDER FDA CLASS 1 RECALL NOTICE. UPDATE: PATIENT REQUIRED A LEFT TKA AFTER SHE FELL. PATIENT HAS EXTREME PAIN WHEN BENDING KNEE, WALKING OR SITTING; SHE HAD FULL MOBILITY PRIOR TO SURGERY. SHE FEELS AS KNEE HAS LOOSENED. RIGHT AFTER SHE HAD SURGERY PATIENT HAS BEEN EXPERIENCING PAIN. PATIENT HAD METAL TEST DONE; IT SHOWED NICKEL IN HER SYSTEM BUT NOT ENOUGH TO SHOW THAT PATIENT WAS HAVING A REACTION. PATIENT STATED THAT DR. (B)(6) TOLD HER THAT SHAPEMATCH WAS NOT USED, HE COULDN'T TELL HER WHAT DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144692 X3 TRIATHLON CS INSERT #2 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH LCW333

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other