BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #7 11MM

    MDR report key: 5990276 · Received September 30, 2016

    Report

    Report Number
    0002249697-2016-03100
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    December 31, 2015
    Report Date
    December 18, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SIMPLEX P - US TOBRA FD 10-PK; CAT# 6197-9-010; LOT# MGW057. SIMPLEX P - US TOBRA FD 10-PK; CAT# 61979010; LOT# MGW058. TRIATHLON PRIM CEM FXD BPLT #7; CAT# 5520-B-700; LOT# AKD3X. TRIATHLON CR FEM COMP #7 R-CEM; CAT# 5510-F-702; LOT# S7HHC. TRIATHLON ASYMMETRIC X3 PATELLA; CAT# 5551-G-350; LOT# 4W5A. 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 REMAINED IMPLANTED IN THE PATIENT AND 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 ARTHROFIBROSIS INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: INDICATED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED. STRYKER ORTHOPAEDICS INDICATES THIS PATIENT¿S IMPLANTS ARE NOT SUBJECT TO A RECALL. FURTHER INFORMATION SUCH AS PRODUCT RETURN, X-RAYS, OPERATIVE NOTES, MEDICAL RECORDS AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION TO DETERMINE A ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT STATED HE HAD RIGHT KNEE SURGERY. CONSTANT PAIN, HAS TO WALK ON HIS TOES. DR. (B)(6) DID A CONTRAST OF KNEE AND KNEE IS SWOLLEN. PATIENT INQUIRED IF LOT NUMBERS ARE ON A RECALL LIST. WAS TOLD POSSIBLE REVISION OF KNEE.

    Description of Event or Problem · 1

    PATIENT STATED HE HAD RIGHT KNEE SURGERY. CONSTANT PAIN, HAS TO WALK ON HIS TOES. DR. (B)(6) DID A CONTRAST OF KNEE AND KNEE IS SWOLLEN. PATIENT INQUIRED IF LOT NUMBERS ARE ON A RECALL LIST. WAS TOLD POSSIBLE REVISION OF KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642171 X3 TRIATHLON CS INSERT #7 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH LES539

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other