BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIATHLON LEFT KNEE REPLACEMENT

    MDR report key: 2121437 · Received June 7, 2011

    Report

    Report Number
    2249697-2011-00822
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    January 28, 2008
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD A STRYKER TRIATHLON LEFT KNEE REPLACEMENT. IT SEEMED FINE AND THEN 3 DAYS LATER THE KNEE BECAME STAPH INFECTED. THE PT THEN HAD TO GO BACK TO REHAB CENTER. PT WAS PUT ON VANCOMYCIN IN THE REHAB CENTER AND CONTINUED MEDICATION AT HOME. HE HAS HAD PAIN EVER SINCE. MOST RECENTLY X-RAYS SHOW THAT THERE IS A SCREW LOOSE AND DETACHING FROM THE TIBIA. THE PAIN IS INHIBITING HIS MOBILITY. THE PT WILL BE RETURNING TO THE DOCTOR'S OFFICE TO MEET WITH AN ASSOCIATE OF THE IMPLANT SURGEON TO CONFIRM IF THE FLUID REMOVED FROM THE LEFT KNEE SHOWS INFECTION. THE FAMILY HAS REQUESTED MEDICAL RECORDS BUT THE HOSPITAL DID NOT INCLUDE THE IMPLANT SHEET. "THEY WILL REQUEST AGAIN SPECIFICALLY FOR THE IMPLANT SHEET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIATHLON LEFT KNEE REPLACEMENT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention