BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4140302 · Received October 3, 2014

    Report

    Report Number
    0002249697-2014-03750
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIDENT CUP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RELATED TO VOLUNTARY RECALL RA 2012-067. THIS RECALL WAS INITIATED DUE TO THE POTENTIAL RISKS ASSOCIATED WITH MODULAR NECK STEMS. THE DEVICE REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DR (B)(6) AT THE CLINIC, REPORTED THE FOLLOWING EVENT: "PLEASE SAVE THIS NEW VIGILANCE CASE MATERIAL ON STRYKER ABGII MODULAR (B)(4). PATIENT FIRST IMPLANTED ON (B)(6) 2011: TOTAL HIP REPLACEMENT (RIGHT) - DUE TO HIP OSTEOARTHRITIS - WITH ABGII MODULAR STEM AND TRIDENT CUP. CONVOCATION OF THE PATIENT FOR CONTROL (AS RECOMMENDED BY THE ANSM MONITORING PROTOCOL). PAINFUL FOR A YEAR. OSTEOLYSIS WITH BONE LOSS OF MORE THAN 1 CM FROM MERKEL. TISSUE REACTION WITH EFFUSION ON ULTRASOUND. COBALT LEVEL 4.8 MICROG/L. REVISION SURGERY PERFORMED THE (B)(6) 2014 - BIPOLAR CHANGE AND MERKEL RECONSTRUCTION WITH BONE GRAFT. TYPICAL GREENISH APPEARANCE OF INTRA-ARTICULAR EFFUSION AND CAPSULAR INFILTRATION. MODULAR NECK CORROSION. INTRA ARTICULAR COBALT LEVEL = 4789 MICROG/L. UNEVENTFUL FOR NOW."

    Description of Event or Problem · 1

    DR (B)(6), SURGEON AT THE CLINIC, REPORTED THE FOLLOWING EVENT : "PLEASE SAVE THIS NEW VIGILANCE CASE MATERIAL ON STRYKER ABGII MODULAR (SURGEON FILE REFERENCE: (B)(4)). PATIENT FIRST IMPLANTED ON (B)(6) 2011 : TOTAL HIP REPLACEMENT (RIGHT) - DUE TO HIP OSTEOARTHRITIS - WITH ABGII MODULAR STEM AND TRIDENT CUP. CONVOCATION OF THE PATIENT FOR CONTROL (AS RECOMMENDED BY THE (B)(4) MONITORING PROTOCOL). PAINFUL FOR A YEAR. OSTEOLYSIS WITH BONE LOSS OF MORE THAN 1 CM FROM MERKEL. TISSUE REACTION WITH EFFUSION ON ULTRASOUND. COBALT LEVEL 4.8 MICROG/L. REVISION SURGERY PERFORMED THE (B)(6) 2014 - BIPOLAR CHANGE AND MERKEL RECONSTRUCTION WITH BONE GRAFT. TYPICAL GREENISH APPEARANCE OF INTRA-ARTICULAR EFFUSION AND CAPSULAR INFILTRATION. MODULAR NECK CORROSION. INTRA ARTICULAR COBALT LEVEL = 4789 MICROG/L. UNEVENTFUL FOR NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618425 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention