BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 3140785 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01839
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MALPOSITION/PAIN INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED THAT THE PATIENT¿S ILIOPSOAS TENDINITIS IS LIKELY DUE TO ACETABULAR MALPOSITION. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. REVIEW OF STRYKERS RECORDS NOTED THAT THIS DEVICE WAS NOT PART OF A RECALL THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE PATIENTS PAIN COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. HOWEVER, IT WAS NOTED BY A CLINICIAN THAT THE PATIENT¿S ILIOPSOAS TENDINITIS IS LIKELY DUE TO ACETABULAR MALPOSITION

    Description of Event or Problem · 1

    VOLUNTARY REPORT NO: (B)(4) STATED: "(B)(4) 2013: POST HIP REPLACEMENT SURGERY WITH USE OF STRYKER ORTHOPAEDIC PRODUCTS; TRIDENT HEMISPHERICAL ACETABULAR SHELL AND SECUR-FIT MAX 127 NECK ANGLE HIP STEM. HIP PAIN DID NOT RESOLVE WITH SURGERY AND ACTUALLY WORSENED EVEN WITH FULL COURSE OF PHYSICAL THERAPY AND APPROPRIATE RECOVERY POST SURGERY. SYMPTOMS EXPERIENCED: PAIN WITH FLEXION AND ROTATION OF LEG, INGUINAL PAIN EXPERIENCED WHEN PERFORMING THE MOTION TO GET IN AND OUT OF VEHICLE AND ASSISTANCE IS NEEDED DUE TO PAIN."

    Description of Event or Problem · 1

    VOLUNTARY REPORT NO: MW5029830 STATED: "VOLUN (B)(6)-2013: POST HIP REPLACEMENT SURGERY WITH USE OF STRYKER ORTHOPAEDIC PRODUCTS; TRIDENT HEMISPHERICAL ACETABULAR SHELL AND SECUR-FIT MAX 127 NECK ANGLE HIP STEM. HIP PAIN DID NOT RESOLVE WITH SURGERY AND ACTUALLY WORSENED EVEN WITH FULL COURSE OF PHYSICAL THERAPY AND APPROPRIATE RECOVERY POST SURGERY. SYMPTOMS EXPERIENCED: PAIN WITH FLEXION AND ROTATION OF LEG, INGUINAL PAIN EXPERIENCED WHEN PERFORMING THE MOTION TO GET IN AND OUT OF VEHICLE AND ASSISTANCE IS NEEDED DUE TO PAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241682 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 32670401

    Patients

    Seq Age Sex Outcome Treatment
    1 Other