BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 33MM

    MDR report key: 4102972 · Received September 19, 2014

    Report

    Report Number
    0002249697-2014-03572
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    April 5, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ADDED TO THIS REPORT: CAT 3704-3-100 D/M 6.5 IN SS BROAD COMP PLATE LOT CODE 41934002; CAT 3704-0-510 2.0MM 22-13-5 SS CABLE/SLV SET LOT CODE 46128002; CAT 3704-0-510 2.0MM 22-13-5 SS CABLE/SLV SET LOT CODE 46496810; CAT 3704-0-510 2.0MM 22-13-5 SS CABLE/SLV SET LOT CODE 46973201; CAT 3704-0-510 2.0MM 22-13-5 SS CABLE/SLV SET LOT CODE 45753705; CAT 6197-9-001 SIMPLEX P WITH TOBRAMYCIN 1 PACK LOT CODE MLU113. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT MADE AVAILABLE. IF ANY INFORMATION IS RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT RELATED TO LOOSENING INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: 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. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAVE RIGHT HIP SURGERY DUE TO FAILURE OF FIXATION WITH NON-UNION RIGHT PROXIMAL FEMUR. PLATE, CABLES, SCREWS, EXETER STEM, AND 32 MM BALL WERE REMOVED AND RETAINED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAVE RIGHT HIP SURGERY DUE TO FAILURE OF FIXATION WITH NON-UNION RIGHT PROXIMAL FEMUR. PLATE, CABLES, SCREWS, EXETER STEM, AND 32 MM BALL WERE REMOVED AND RETAINED BY THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAVE RIGHT HIP SURGERY DUE TO FAILURE OF FIXATION WITH NON-UNION RIGHT PROXIMAL FEMUR. PLATE, CABLES, SCREWS, EXETER STEM, AND 32 MM BALL WERE REMOVED AND RETAINED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584470 EXETER V40 STEM 33MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH G3319221

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention