BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 28X45MM

    MDR report key: 4225257 · Received November 4, 2014

    Report

    Report Number
    0002249697-2014-04177
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. VISUAL INSPECTION: INSPECTION OF THE RETURNED BIPOLAR HEAD WAS UNREMARKABLE. SOME LIGHT SCRATCHING CONSISTENT WITH IN-VIVO USE WAS OBSERVED ON THE ARTICULATING SURFACES. THE POLY LOCKING RING IS UNDAMAGED. DIMENSIONAL INSPECTION: NOT PERFORMED AS THE DEVICES WERE AUTOCLAVED UPON RECEIPT AT STRYKER ORTHOPAEDICS AND THUS THE DEVICES DIMENSIONS WERE ALTERED. NC WAS INITIATED TO ADDRESS THIS ISSUE. FUNCTIONAL INSPECTION: NOT PERFORMED AS THE DEVICES WERE AUTOCLAVED UPON RECEIPT AT STRYKER ORTHOPAEDICS AND THUS THE DEVICES DIMENSIONS WERE ALTERED. NC WAS INITIATED TO ADDRESS THIS ISSUE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    WHILE IN A SITTING POSITION, PT BENT OVER TO TIE HER SHOES. SHE APPARENTLY BENT ACROSS HER BODY, AND THE PRIMARY BIPOLAR DISLOCATED. WHILE IN ER THE ORTHOPAEDIC PA ATTEMPTED SEVERAL METHODS TO RELOCATE IMPLANT INTO ACETABULUM WITH A STRAIGHT TRACTION PULL THE HIP AND WAS REDUCED. POST REDUCTION X-RAYS REVEALED THE UNIVERSAL HEAD HAD DISASSOCIATED WITH THE C-TAPER HEAD DURING REDUCTION.

    Description of Event or Problem · 1

    WHILE IN A SITTING POSITION, PT BENT OVER TO TIE HER SHOES. SHE APPARENTLY BENT ACROSS HER BODY, AND THE PRIMARY BIPOLAR DISLOCATED. WHILE IN ER THE ORTHOPAEDIC PA ATTEMPTED SEVERAL METHODS TO RELOCATE IMPLANT INTO ACETABULUM WITH A STRAIGHT TRACTION PULL THE HIP AND WAS REDUCED. POST REDUCTION X-RAYS REVEALED THE UNIVERSAL HEAD HAD DISASSOCIATED WITH THE C-TAPER HEAD DURING REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706990 UHR BIPOLAR 28X45MM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH MNEEMD

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention