BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 58MM

    MDR report key: 2925384 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00149
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED. THE MAR CONCLUDED THAT THE SLEEVE OF THE TRIDENT INSERT/SLEEVE ASSEMBLY SHOWED LIKELY IMPINGEMENT. THE WEAR SCAR ON BOTH THE INSERT AND THE FEMORAL HEAD WAS FAIRLY LARGE WITH EDGE LOADING OCCURRING SUPPORTING THE IMPINGEMENT INDICATIONS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE SHELL WAS UNREMARKABLE. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS OPERATIVE REPORTS, XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 625-0T-36G, LOT # 15814303, DESCRIPTION: TRIDENT ALUMINA INSERT. CAT # 17-3600E, LOT # 11761001, DESCRIPTION: ALUMINA C-TAPER HEAD 36MM/0. CAT # 2030-6520-1, LOT # 35215004, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 20MM. CAT # 2060-0000-1, LOT # 37290104, DESCRIPTION: ACETABULAR DOME HOLE PLUG. CAT # 2030-6516-1, LOT # 35941703, DESCRIPTION: 6.5 CANCELLOUS BONE SCREW 16MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS HAVING PAIN OF A CERAMIC ON CERAMIC TOTAL HIP. REVISION WAS PERFORMED. ACETABULAR SHELL, LINER, AND FEMORAL HEAD REMOVED AND REPLACED WITH TRITANIUM SHELL, MDM LINER, AND 28MM FEMORAL HEAD.

    Description of Event or Problem · 1

    PATIENT WAS HAVING PAIN OF A CERAMIC ON CERAMIC TOTAL HIP. REVISION WAS PERFORMED. ACETABULAR SHELL, LINER, AND FEMORAL HEAD REMOVED AND REPLACED WITH TRITANIUM SHELL, MDM LINER, AND 28MM FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30731 TRIDENT PSL HA CLUSTER 58MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 34543701

    Patients

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