BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 4140317 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03738
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 17-2805 ABC ALUMINA C-TAPER HEAD 28MM, +5MM NK LOT CODE 51295. UNKNOWN SCREWS X 2. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING PAIN AND WEAR INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). "A WEAR SCAR WAS OBSERVED NEAR THE RIM OF THE ARTICULATING INSERT." THE MAR CONCLUDED: "NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON ANY OF THE COMPONENTS EXAMINED." MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: "REVISION OF A HEMIARTHROPLASTY TO A TOTAL HIP ARTHROPLASTY IS FREQUENTLY DUE TO PROGRESSIVE OSTEOARTHRITIS OF THE HOST ACETABULUM ARTICULATING WITH THE METALLIC HEMIARTHROPLASTY. THE DESCRIPTION OF STRIPE WEAR MAY HAVE RESULTED FROM SUBLUXATION OF THE CERAMIC HEAD ONTO THE RIM OF THE ACETABULAR COMPONENT. THERE IS NO EVIDENCE THAT THIS PATIENT¿S CLINICAL PROBLEMS WERE THE RESULT OF FAULTY PROSTHETIC COMPONENT DESIGN, MANUFACTURING, OR MATERIALS." 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 MEDICAL REVIEW WAS PERFORMED AND DID NOT INDICATE ANY EVIDENCE OF A DEVICE RELATED ISSUE, FURTHER TO THIS A MATERIAL ANALYSIS WAS PERFORMED AND NO MATERIAL OR MANUFACTURING DEFECTS WERE IDENTIFIED ON THE SURFACES EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT APPARENTLY IN AUTO ACCIDENT SEVERAL YEARS AGO (2003), BIPOLAR PROSTHESIS WAS IMPLANTED, THEN REVISED TO SECUREFIT STEM AND CERAMIC HEAD AND LINER, ALL STRYKER. SHE PRESENTED TO DR WITH GRINDING AND GROIN PAIN. DR TOOK OUT LINER, HEAD AND TWO SCREWS, CUP/STEM WELL FIXED. REPLACED LINER AND HEAD WITH A STRYKER MDM AND METAL C TAPER HEAD. NOT AWARE OF ANY FORMER PER'S THAT MAY HAVE BEEN REPORTED ON THIS PATIENT. PREVIOUS SURGEON RETIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT APPARENTLY IN AUTO ACCIDENT SEVERAL YEARS AGO (2003), BIPOLAR PROSTHESIS WAS IMPLANTED, THEN REVISED TO SECUREFIT STEM AND CERAMIC HEAD AND LINER, ALL STRYKER. SHE PRESENTED TO DR WITH GRINDING AND GROIN PAIN. DR TOOK OUT LINER, HEAD AND TWO SCREWS, CUP/STEM WELL FIXED. REPLACED LINER AND HEAD WITH A STRYKER MDM AND METAL C TAPER HEAD. NOT AWARE OF ANY FORMER PER'S THAT MAY HAVE BEEN REPORTED ON THIS PATIENT. PREVIOUS SURGEON RETIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617976 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH U5191601

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention