BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION PHS

    MDR report key: 936236 · Received October 30, 2007

    Report

    Report Number
    1651501-2007-00026
    Event Type
    Other
    Date Received
    October 30, 2007
    Date of Event
    September 19, 2007
    Report Date
    October 26, 2007
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTRODUCTION: IT WAS REPORTED THAT AN ASCENSION PHS SIZE 20 IMPLANT WAS REMOVED FROM A PATIENT'S LEFT THUMB BY DR. IN 2007. THE IMPLANT WAS REMOVED BECAUSE OF PAIN, LOOSENING AND SUBSIDENCE. THE ASCENSION IMPLANT, AND TISSUE FROM THE METACARPAL AND TRAPEZIUM WERE REMOVED AND RETURNED TO ASCENSION ORTHOPEDICS FOR ANALYSIS. THE LOT NUMBER OF THE IMPLANT WAS NOT AVAILABLE. THE CUSTOMER FEEDBACK RECORD WAS THEN REVIEWED TO UNDERSTAND THE SEQUENCE OF EVENTS THAT OCCURRED DURING IMPLANTATION AS RELATED BY THE USER AND ANY OTHER INFO PROVIDED BY THE FIELD. A VISUAL EXAMINATION OF THE IMPLANTS WAS PERFORMED ASSISTED BY A STEREOMICROSCOPE AND OBLIQUE LIGHTING. TISSUE SPECIMENS WERE SUBMITTED TO A PATHOLOGIST, DR. VICTOR SALDIVAR OF PATHOLOGICAL REFERENCE LABORATORY, LLC FOR ANALYSIS. RESULTS: VISUAL EXAMINATION AIDED WITH A STEREOMICROSCOPE REVEALED THAT THE RETRIEVED IMPLANT WAS INTACT WITH MINIMAL MARKINGS. SEE FIGS 1 THROUGH 4. SLIGHT POLISHING AND/OR WITNESS MARKS DUE TO BONE APPOSITION WERE PRESENT ON THE STEMS AS SHOWN IN FIG 5 THROUGH 8. THE ARTICULATING SURFACE DEMONSTRATED NO SIGNS OF WEAR. SEE FIGURES 9 AND 10. THE PATHOLOGY REPORT IS ATTACHED. DISCUSSION: SOME NOTABLE OBSERVATIONS IN THE PATHOLOGY REPORT WERE THE FOCAL "MUMMIFICATION" OF VILLI AND ENTRAPPED BONY SPICULES IN THE THUMB CAPSULE AND TRAPEZIUM. THESE ARE DEAD MATERIALS, WITH DEATH OCCURRING BY DRILLING OR EXPOSURE TO A FOREIGN COMPRESSIVE STRESS IN CONTRAST TO AN INFLAMMATORY NECROTIC PROCESS. NON-BIREFRINGENT, LOOSE AND MINIMALLY INTRACELLULAR BLACK PIGMENT WAS OBSERVED FOCALLY IN THE TRAPEZIUM AND THUMB METACARPAL CANAL SPECIMENS. THESE PIGMENTS ARE CONSISTENT WITH PREVIOUS OBSERVATIONS FROM RIB RECONSTRUCTION METALLIC IMPLANTS AND COULD ALSO POSSIBLY BE CARBON PARTICLES. A NUMBER OF REACTIVE PROCESSES WERE OBSERVED: FIBROSIS, CAULIFLOWER PAPILLAE, PROLIFERATION OF SYNOVIUM AND HYPERVASCULARITY, PERHAPS IN RESPONSE TO IRRITATION. THE SLIGHT BURNISHING WITNESS MARKS NOTED IN THE PHS STEM COULD POSSIBLY BE THE SOURCE OF THE BLACK PIGMENT. BUT, THE EXTENT OF BURNISHING WEAR WAS EXTREMELY SLIGHT, SO ONLY A VERY SMALL AMOUNT OF PARTICLES COULD HAVE BEEN PRODUCED. METAL FRAGMENTS FROM THE K-WIRE CANNULATED BURR ARE ALSO A POSSIBLE SOURCE. HOWEVER, THE SMALL FOCAL AMOUNT OF PIGMENT OBSERVED IS NOT LIKELY TO HAVE PRODUCED THE SUBSIDENCE AND LOOSENING. CONCLUSIONS: THE PROSTHESIS WAS INTACT. WEAR MARKINGS ON THE PROSTHESIS WERE MINIMAL. THERE WAS NOTHING REMARKABLE ABOUT THE IMPLANT THAT COULD LEAD TO PAIN, SUBSIDENCE AND LOOSENING.

    Description of Event or Problem · 1

    SURGEON PERFORMED A REVISION ON PATIENT AS A RESULT OF POST-OP PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PHS CARPOMETACARPAL (CMC) IMPLANT KYI ASCENSION ORTHOPEDICS, INC. PHS-440 06-2002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other