BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 2103827 · Received May 18, 2011

    Report

    Report Number
    2249697-2011-00740
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE LISTED IN THIS REPORT: TRIATHLON-CR FEMORAL COMPONENT CEMENTED #4 RIGHT CAT # 5510-F-401, LOT # SPCFK; TRIATHLON ASYMMETRIC X3 PATELLA CAT # 5551-G-320, LOT # 942X. TRIATHLON CR X3 TIBIAL INSERT CAT # 5530-G-416, LOT # 6RYMKA. PINABALL PRELOADED PINS CAT # 6003-003-090, LOT # K7Q01F87FN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN EVAL OF THE REPORTED 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. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON REC'D A LAW SUIT THAT ALLEGES THAT HE IMPLANTED STRYKER TOTAL KNEE RECALLED IMPLANTS." ADD'L INFO: "THE PT HAS NOT BEEN REVISED AND WAS DISCHARGED WITH NO PAIN. THE PT IS SEEING A PAIN DOCTOR, BUT WE DON'T KNOW IF IT IS FOR HIS KNEE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA ZAFIA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other