BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 4.5

    MDR report key: 4241446 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04223
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING PAIN AND LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -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 BECAUSE 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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). IMAGES OF THE DEVICE ARE INCLUDED IN THE MAR. "A REPRESENTATIVE IMAGE OF THE TRUNNION SURFACE IS SHOWN IN FIGURE 3. A REPRESENTATIVE IMAGE OF THE FEMORAL HEAD TAPER IS SHOWN IN FIGURE 4. DARK ADHERED DEBRIS AND SURFACE TEXTURE VARIATIONS WERE OBSERVED WITHIN THE TAPER JUNCTION REGION OF BOTH DEVICES." THE MAR CONCLUDED THAT THERE WAS "NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICES EXAMINED." A DIMENSIONAL INSPECTION CONFIRMED THAT THE RETURNED STEM CONFORMED TO THE REQUIRED PROFILES AS PER OPERATION SEQUENCE. A REVIEW OF THE DHR ALSO DID NOT INDICATE ANY EVIDENCE OF A DIMENSIONAL ISSUE MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "AS SUCH IS ANY ELEVATED CORROSION PROCESS SECONDARY TO THE STEM LOOSENING AND NOT VICE VERSA. WITH REGARD TO THE CAUSE OF THE STEM LOOSENING WE ARE STILL IN THE BLIND. THE CURRENT NEW MAR INFO DOES NOT ADD ANYTHING TO UNDERSTAND WHY THE STEM FAILED IN THE FIRST PLACE. SO, LACK OF ADEQUATE INFO REMAINS A HANDICAP TO SOLVE THIS CASE." 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: A MATERIAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE WAS NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICES EXAMINED. THE EXACT CAUSE OF THE EVENT HOWEVER COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. ADDITIONAL INFORMATION, INCLUDING PROGRESS NOTES AND FURTHER X RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BURSECTOMY, DUE TO THE PATIENT COMPLAINING OF HIP PAIN, AFTER EXCHANGING THE POLY THE DOCTOR PULLED ON THE STEM AND REALIZED IT WAS LOOSE. HE THEN EXTRACTED THE STEM AND REIMPLANTED AN ACCOLADE 2.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BURSECTOMY, DUE TO THE PATIENT COMPLAINING OF HIP PAIN, AFTER EXCHANGING THE POLY THE DOCTOR PULLED ON THE STEM AND REALIZED IT WAS LOOSE. HE THEN EXTRACTED THE STEM AND REIMPLANTED AN ACCOLADE 2.

    Description of Event or Problem · 1

    THE DOCTOR WAS PERFORMING A BURSECTOMY, DUE TO THE PATIENT COMPLAINING OF HIP PAIN, AFTER EXCHANGING THE POLY THE DOCTOR PULLED ON THE STEM AND REALIZED IT WAS LOOSE. HE THEN EXTRACTED THE STEM AND REIMPLANTED AN ACCOLADE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722735 ACCOLADE 132 SIZE 4.5 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 30143305

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention