BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 2338089 · Received November 7, 2011

    Report

    Report Number
    2249697-2011-01559
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    October 12, 2011
    Report Date
    October 12, 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
    GA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON-PRIM TIB BASEPLATE, CAT# 5520-B-500, LOT# STAYK; TRIATHLON PS FEM COMPONENT, CEMENTED, CAT# 5515-F-402, LOT# DKUH; SIMPLEX P WITH TOBRA UNIT PACKFULL DOSE, CAT# 6197-9-001, LOT# MCR011. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THEY REMAINED IMPLANTED. DISCUSSION WITH THE MEDICAL ASSISTANT FOR THIS CASE INDICATED THE PATIENT IS ONLY INTERESTED IN KNOWING IF THE DEVICES ARE PART OF RECALL AND NO ADDITIONAL PATIENT MEDICAL RECORDS ARE AVAILABLE FOR INVESTIGATION. A REVIEW OF THE IMPLANT SHEET DETERMINED NONE OF THE IMPLANTED DEVICES ARE PART OF ANY STRYKER RECALL. THE DHRS FOR THE REPORTED DEVICES INDICATE THAT THEY WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES RELATED TO THIS EVENT. THE RESULTS OF THE PER DATABASE REVIEW INDICATED THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR REPORTED LOTS OF PRODUCT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PATIENT REQUESTED THAT (B)(6) A MEDICAL ASSISTANT AT HER DOCTOR'S OFFICE, FILE A REPORT/INQUIRY INTO HER RIGHT KNEE IMPLANTS. THE PATIENT IS HAVING POPPING AND PAIN IN THE RIGHT KNEE. SHE FEELS HARDNESS IN THE KNEE AND DOES NOT KNOW IF IT IS SCAR TISSUE. SHE HAS HEARD OF PRODUCT RECALLS AND WANTS 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 MET9M2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other