BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 1541959 · Received November 13, 2009

    Report

    Report Number
    2249697-2009-00804
    Event Type
    Injury
    Date Received
    November 13, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 16, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ASSOCIATED SCREWS WERE ALSO LISTED IN THIS REPORT: GAP PLATE SCREWS; CAT# 2080-0020; LOT 9AKMKD. GAP PLATE SCREWS; CAT# 2080-0030; LOT 936MMA. GAP PLATE SCREWS; CAT# 2080-0035; LOT T9MMMA. GAP PLATE SCREWS; CAT# 2080-0040; LOT 26035001. C-TAPER FEMORAL HEAD; CAT# 06-3605; LOT 2JRMKE. TRIDENT TRITANIUM HEMISPHERICAL SHELL; CAT# 509-02-56E; LOT EVLMAE. TRIDENT X3; CAT# 643-00-36E; LOT K9JMRD. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE LOOSENING OF THE PT'S ACETABULAR COMPONENT. ADDITIONAL INFO HAS BEEN REQUESTED AND IF AVAILABLE, IT WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PT IS A FEMALE WHO HAD A RIGHT TOTAL HIP ARTHROPLASTY SEVERAL YRS AGO. IT DID WELL UNTIL APPROXIMATELY TWO YRS AGO, AND THEN SHE STARTED HAVING INCREASING PAIN AND LOOSENING OF HER ACETABULAR COMPONENT. ONE YR AGO, SHE HAD REVISION ARTHROPLASTY WITH STRYKER ACETABULAR SYSTEM. SHE DID WELL WHEN SHE STARTED HAVING PAIN AND LIMPING AGAIN. SHE CAME TO THE CLINIC WHERE FAILURE OF HER SCREWS AND HER CUP WERE IDENTIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA EVLMAE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R