BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 4100053 · Received September 18, 2014

    Report

    Report Number
    0002249697-2014-03548
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A FRACTURED STEM INVOLVING AN EXETER STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE EXETER STEM FRACTURED IN FATIGUE WITH THE APPROXIMATE ORIGIN ON THE LATERAL SIDE OF THE STEM. THE STEM MATERIAL WAS CONSISTENT WITH THE ASTM F1586 AND ISO 5832-9 STAINLESS STEEL ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE PART FEATURES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW CONCLUDED ¿CYCLIC LOADING AT THE JUNCTION OF THE PROXIMAL LOOSE AND WELL-FIXED DISTAL STEM SEGMENTS RESULTED IN THE INEVITABLE FRACTURE. THERE IS NO EVIDENCE THAT MANUFACTURING OR MATERIALS DEFECTS WERE RESPONSIBLE FOR THIS STEM FRACTURE.¿ -DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: A MATERIAL ANALYSIS CONCLUDED THE STEM FRACTURED IN FATIGUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE PARTS EXAMINED. ADDITIONALLY, A MEDICAL REVIEW CONCLUDED THAT CYCLIC LOADING AT THE JUNCTION OF A PROXIMALLY LOOSE AND DISTALLY WELL FIXED STEM LED TO AN INEVITABLE FRACTURE. THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED BY SURGEON OF THE HOSPITAL, THAT THE PATIENT HAVE HAD A HETP IMPLANTATION (B)(6) 2009. AFTER HE FELL DOWN ON HIS RIGHT SIDE HE CAME IN WITH PAIN (B)(6) 2014. NO FRACTURE WAS VISIBLE ON X-RAY (B)(6) 2014. AFTER SUSTAINED PAIN, WHICH EMANATED INTO THE THIGH, THEY MADE ANOTHER X-RAY TO CONTROL (B)(6) 2014. THIS TIME A FRACTURE WAS VISIBLE. THE EXCETER V40 STEM WAS BROKEN. THE PATIENT NEEDED TO UNDERGO A REVISION SURGERY (B)(6) 2014.

    Description of Event or Problem · 1

    IT IS REPORTED BY SURGEON OF THE HOSPITAL, THAT THE PATIENT HAVE HAD A HETP IMPLANTATION (B)(6) 2009. AFTER HE FELL DOWN ON HIS RIGHT SIDE HE CAME IN WITH PAIN (B)(6) 2014. NO FRACTURE WAS VISIBLE ON X-RAY (B)(6) 2014. AFTER SUSTAINED PAIN, WHICH EMANATED INTO THE THIGH, THEY MADE ANOTHER X-RAY TO CONTROL (B)(6) 2014. THIS TIME A FRACTURE WAS VISIBLE. THE EXCETER V40 STEM WAS BROKEN. THE PATIENT NEEDED TO UNDERGO A REVISION SURGERY (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578333 EXETER V40 STEM 35.5MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G2583259

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention