BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 6154617 · Received December 8, 2016

    Report

    Report Number
    0002249697-2016-03859
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 10, 2016
    Report Date
    March 20, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON SYMMETRIC X3 PATELLA; CAT# 5550-G-339; LOT# NWK6 TRIATHLON FIX. PEG 2 PER PK; CAT# 5575-X-000; LOT# EKJ7R TRIATHLON PS FEM COMPONENT, CEMENTED; CAT# 5515-F-601; LOT# JWXUA TRIATHLON PRIM TIB BASEPLATE - CEMENTED; CAT# 5520-B-600; LOT# KJLEA UNKNOWN DEVICE; CAT# REPORTED AS 00-1112-140-01; LOT# 77604366 IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON INSERT WAS REPORTED. CONCLUSION: THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT SINCE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. NO OTHER ALLEGATIONS WERE MADE AGAINST THE INSERT THEREFORE IT IS CONSIDERED AS CONCOMITANT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    HIS KNEE KEEPS GIVING OUT DUE TO PAIN. KNEE KEEPS POPPING OUT OF PLACE. HE HAS FALLEN 20 TIMES. A SCHEDULED REVISION ON MONDAY (B)(6) 2016 DUE TO PAIN.

    Description of Event or Problem · 1

    HIS KNEE KEEPS GIVING OUT DUE TO PAIN. KNEE KEEPS POPPING OUT OF PLACE. HE HAS FALLEN 20 TIMES. A SCHEDULED REVISION ON MONDAY (B)(6) 2016 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805507 TRIATHLON PS X3 TIBIAL INSERT PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH MNMPR1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other