BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 2221527 · Received August 11, 2011

    Report

    Report Number
    2249697-2011-01195
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    October 27, 2010
    Report Date
    July 22, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON PS FEM COMPONENT, CEMENTED, CAT# 5515-F-401, LOT# DRKN. TRIATHLON-PRIM TIB BASEPLATE USAE MOLD #1434, CAT# 5520-B-500, LOT# SXCSA. TRIATHLON ASYMMETRIC X3 PATELLA, CAT# 5551-G-320, LOT# B042. TRIATHLON FEMORAL PEG, MODULAR DISTAL FIXATION, CAT# 5575-X-000, LOT# SYAEY. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT PAIN. AN EVAL OF THE DEVICES CANNOT BE PERFORMED AS THE DEVICES REMAINED IMPLANTED IN THE PT AND WERE NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE RIGHT KNEE IMPLANT HAS NO PROBLEMS AT ALL. THE PT IS HAVING A LOT OF ISSUES WITH HER LEFT KNEE IMPLANT. THE ENTIRE KNEE IS PAINFUL. SHE HAS SWELLING AND CANNOT WALK OR RIDE IN A CAR FOR VERY LONG. THE DOCTOR DREW BLOOD FROM THE KNEE, BUT NO INFECTION WAS FOUND. A SCOPE WAS DONE TO SEE IF THERE IS ANY SCARRING CAUSING PAIN. THE TEST DID NOT REVEAL ANY SCARRING. THE SURGEON THEN ADVISED THAT THE PT HAD TO WAIT A YEAR FOR FURTHER ASSESSMENT. THE PT CANNOT PARTICIPATE IN HER REGULAR ACTIVITIES WITH HER FAMILY. SHE WOULD LIKE TO KNOW IF ANY OF HER IMPLANTS HAVE BEEN RECALLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MJK7LK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other