BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 3032092 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01176
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE ACCOLADE STEM SHOWS SIGNIFICANT BONE ONGROWTH ON THE DISTAL REGION OF THE COATED AREA OF THE DEVICE, WHICH IS AN INDICATION OF GOOD FIXATION OF THE STEM. THERE IS NOT AS MUCH BONE ONGROWTH PROXIMALLY. THE NECK AREA OF THE STEM IS UNREMARKABLE APART FROM MINOR SCRATCHING FROM EXPLANTATION. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, X-RAYS AND PATIENT MEDICAL RECORDS WOULD BE HELPFUL IN INVESTIGATING THIS EVENT FURTHER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    REMOVAL OF AN ACCOLADE TMZF #3 127, ALUMINA LINER F, AND ALUMINA HEAD 32 STANDARD HEAD WAS REPORTED. ON (B)(4) 2013: ADDITIONAL INFORMATION PROVIDED IN THE ORTHOPEDIC CONSULTATION REPORT INDICATED THAT THE PATIENT PRESENTED WITH PAIN STATUS LEFT THA. X-RAY AND CT SCAN CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. THIS PATIENT DID RECEIVE RADIATION AND IT WAS NOTED THAT BONY GROWTH WOULD PROBABLY BE COMPROMISED.

    Description of Event or Problem · 1

    REMOVAL OF AN ACCOLADE TMZF #3 127, ALUMINA LINER F, AND ALUMINA HEAD 32 STANDARD HEAD WAS REPORTED. ON (B)(6) 2013: ADDITIONAL INFORMATION PROVIDED IN THE ORTHOPEDIC CONSULTATION REPORT INDICATED THAT THE PATIENT PRESENTED WITH PAIN STATUS LEFT THA. X-RAY AND CT SCAN CONFIRMED LOOSENING OF THE FEMORAL COMPONENT. THIS PATIENT DID RECEIVE RADIATION AND IT WAS NOTED THAT BONY GROWTH WOULD PROBABLY BE COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136854 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 23108503

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O| R