BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT CR#2 11MM

    MDR report key: 2991076 · Received March 6, 2013

    Report

    Report Number
    0002249697-2013-00920
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 29, 2012
    Report Date
    January 30, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TRIATHLON RIGHT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 5520-B-200, TRIATHLON PRIM CEM FXD BPLT #2, LOT CODE: ST76H. CAT. NO.: 5510-F-202, TRIATHLON CR FEM COMP #2 R-CEM, LOT CODE: S6AMB. THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN, SNAPPING, POPPING, LOCKING IN THE KNEE INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS DEVICE RETURN, PRE- AND POST-OPERATIVE X-RAYS, PRIMARY AND REVISION OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PATIENT HAS EXPERIENCED INTENSE PAIN, SNAPPING, POPPING AND LOCKING IN THE KNEE SINCE IMPLANTATION. PATIENT HAS FALLEN SEVERAL TIMES IN THE LAST MONTH DUE TO THE KNEE CATCHING AND CANNOT WALK WITHOUT THE USE OF A CANE. THERE IS VISIBLE SWELLING AROUND THE ENTIRE KNEE. PATIENT WANTS TO BE ADVISED IF THE IMPLANT WAS RECALLED AND IF SIMILAR ISSUES ARE COMMON.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PATIENT HAS EXPERIENCED INTENSE PAIN, SNAPPING, POPPING AND LOCKING IN THE KNEE SINCE IMPLANTATION. PATIENT HAS FALLEN SEVERAL TIMES IN THE LAST MONTH DUE TO THE KNEE CATCHING AND CANNOT WALK WITHOUT THE USE OF A CANE. THERE IS VISIBLE SWELLING AROUND THE ENTIRE KNEE. PATIENT WANTS TO BE ADVISED IF THE IMPLANT WAS RECALLED AND IF SIMILAR ISSUES ARE COMMON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PATIENT ADVISED SHE HAD A REVISION ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95140 X3 TRIATHLON INSERT CR#2 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBN085

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other