BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 3071398 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01361
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 1, 2011
    Report Date
    March 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT:CAT # 502-01-56F, LOT # 16100401, DESCRIPTION: TRIDENT HEMISPHERICAL CLUSTER 56MM;CAT # 623-10-32F, LOT # 37245401, DESCRIPTION: TRIDENT 10° X3 INSERT 32MM ID;CAT # 6565-0-132, LOT # 12943802, DESCRIPTION: ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK.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 A SUPPLEMENTAL REPORT. (B)(4): DEVICE IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING ACETABULAR LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE SUBJECT FEMORAL STEM DOES NOT INTERFACE WITH THE PATIENT'S ACETABULAR BONE. CLINICIAN REVIEW OF THE PROVIDED RECORDS FOUND NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN IN HIS LEFT HIP AND IN THE FRONT OF THE THIGH AREA. PATIENT HAD A STEROID INJECTION BACK IN (B)(6) OF 2012. PATIENT HAS HAD X-RAYS AND HAS A NEW SURGEON, WHO IS ADVISING THE PATIENT TO HAVE REVISION SURGERY IN THE NEXT THREE MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN IN HIS LEFT HIP AND IN THE FRONT OF THE THIGH AREA. PATIENT HAD A STEROID INJECTION BACK IN (B)(6) OF 2012. PATIENT HAS HAD X-RAYS AND HAS A NEW SURGEON, WHO IS ADVISING THE PATIENT TO HAVE REVISION SURGERY IN THE NEXT THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172392 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 14803704

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other