BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 2155494 · Received June 30, 2011

    Report

    Report Number
    2249697-2011-00981
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    January 5, 2010
    Report Date
    June 7, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER KNEE DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON-CR FEMORAL COMPONENTCEMENTED #4 LEFT; CAT# 5510-F-401; LOT SPENB. X3 TRIATHLON CS INS SIZE4 11MM; CAT# 5531-G-411; LOT LBS690. TRIATHLON ASYMMETRIC X3 PATELLA; CAT# 5551-G-350; LOT 909A. SIMPLEX P - US TOBRA FD 10-PK; CAT# 6197-9-010; LOT# MLP062. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. AN EVALUATION OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) REMAINED IMPLANTED IN THE PATIENT WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS GIVING HER KNEE REPLACEMENT TIME TO HEAL BUT CONTINUED TO EXPERIENCE SEVERE PAIN. THE SURGEON X-RAYED THE KNEE IN (B)(6) 2010 AND SAID SHE NEEDED MORE RECOVERY TIME. ONE YEAR AFTER THE INITIAL SURGERY, THE PATIENT IS STILL EXPERIENCING EXTREME PAIN. THE PATIENT RETURNED TO HER SURGEON WHO WAS UNCOOPERATIVE AND THE PATIENT WENT FOR A SECOND OPINION APPROXIMATELY (B)(6) OF 2011. X-RAYS AND MRI WERE DONE DURING THAT TIME AND THE NEW SURGEON, DOCTOR (B)(6) STATED THAT SHE NEEDS A REVISION SURGERY WHICH IS SCHEDULED (B)(6), 2011."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other