BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 54MM

    MDR report key: 3984193 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03021
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING SHELL LOOSENING INVOLVING A TRIDENT HEMISPHERICAL CLUSTER 54MM WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED: "REGARDING THE REFERENCED PI, THIS CASE REPRESENTS A MALE PATIENT WHOSE DATE OF BIRTH IS (B)(6) 1957, AND WHO IS DESCRIBED AS (B)(6). IN (B)(6) OF 2007 HE APPARENTLY UNDERWENT A PRIMARY LEFT TOTAL HIP ARTHROPLASTY. ON (B)(6) 2014 A CONSULTATION DESCRIBED, ¿NEVER GOOD RELIEF AFTER SURGERY, FOUR-PRONG CANE SINCE, PAIN LEVEL SIX OVER TEN¿. THE PATIENT WAS TAKING OXYCODONE EVERY FOUR HOURS. ON (B)(6) 2014 A REVISION OF A LOOSE ACETABULAR COMPONENT OF THE LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A DIAGNOSIS OF LOOSE LEFT ACETABULAR COMPONENT. THE OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND AN ANTEROLATERAL APPROACH. THE FEMORAL COMPONENT WAS DESCRIBED AS STABLE AND THE ACETABULAR COMPONENT WAS LOOSE AND EASILY REMOVED. THE ACETABULUM WAS SUBSEQUENTLY REAMED TO 58 MILLIMETERS FOR A 58 TRITANIUM REVISION SHELL WITH FOUR SCREWS. A 36/0° X3 INSERT AND A 36/0 BIOLOX HEAD WITH A V-40/C-TAPER SLEEVE ON THE RETAINED STEM WERE ALSO UTILIZED. UNCOMPLICATED SURGERY WAS DESCRIBED. X-RAY COPIES AVAILABLE FOR REVIEW, ALL UNDATED, INCLUDE AN AP OF THE PELVIS AND AN AP AND LATERAL OF THE LEFT HIP DEMONSTRATING AN UNCEMENTED LEFT TOTAL HIP ARTHROPLASTY WITH NO SCREWS IN THE ACETABULUM. THE HIP IS REDUCED AND THE STEM IS IN NOMINAL POSITION. THE ACETABULUM DEMONSTRATES THREE-ZONE LUCENCIES IN ITS PERIPHERY WITH THE CUP MIGRATED TO A VERTICAL POSITION. ANOTHER AP OF THE PELVIS AND AP AND LATERAL OF THE LEFT HIP DEMONSTRATES THE SAME STEM AND A NEW ACETABULAR SHELL WITH FOUR SCREWS. THE HIP IS REDUCED AND THE COMPONENTS ARE NOW IN NOMINAL POSITION. NO CLINICAL OR PAST MEDICAL HISTORY, NO PRIMARY LEFT TOTAL HIP ARTHROPLASTY OPERATIVE REPORT, AND NO EXAMINATION OF THE EXPLANTED COMPONENTS ARE AVAILABLE. BASED UPON THE DOCUMENTATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THE LOOSE LEFT ACETABULAR COMPONENT REQUIRING REVISION SURGERY SEVEN YEARS STATUS-POST IMPLANTATION." DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT MEDICAL RECORDS WERE PROVIDED. CLINICAL CONSULTANT¿S MEDICAL REVIEW INDICATED THAT BASED UPON THE DOCUMENTATION AVAILABLE FOR REVIEW, NO DETERMINATION CAN BE MADE REGARDING THE CAUSE OF THE LOOSE LEFT ACETABULAR COMPONENT REQUIRING REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO A LOOSE ACETABULAR SHELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO A LOOSE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461501 TRIDENT HEMISPHERICAL CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 23191801

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R