BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABG II CUP&CERAMIC INS PK N/HL

    MDR report key: 4017539 · Received August 18, 2014

    Report

    Report Number
    0002249697-2014-03132
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    September 20, 2012
    Report Date
    September 4, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN HIP PROSTHESIS. THE INFORMATION IN THIS REPORT WAS PROVIDED BY COMPETENT AUTHORITY IN IRELAND. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A LETTER WAS RECEIVED FROM THE INJURIES BOARD (B)(6) IN RELATION TO A MALE PATIENT WHO INTENDS TO SEEK COMPENSATION FROM STRYKER FOR ALLEGED PERSONAL INJURY. THE INJURIES BOARD REPORTED THAT ON (B)(6) 2012, THE PATIENT VISITED HIS GP, COMPLAINING OF AN UNUSUAL SENSATION IN HIS RIGHT KNEE FOLLOWING TOTAL HIP REPLACEMENT. THE INJURIES BOARD REPORTED THAT THE GP REFERRED THE PATIENT TO ORTHOPAEDIC SURGEON WHO ADVISED THAT THE PATIENT HAD DEVELOPED A SQUEAKING OF HIS RIGHT HIP. THE SURGEON FURTHER ADVISED THAT REVISION SURGERY WOULD BE REQUIRED AND SUBSEQUENTLY PERFORMED A TOTAL HIP REPLACEMENT REVISION PROCEDURE AT THE HOSPITAL ON (B)(6) 2012. THE INJURIES BOARD REPORTED THAT APPROXIMATELY 5 - 6 MONTHS POST SURGERY, THE PATIENT DEVELOPED SIGNIFICANT PROBLEMS INCLUDING DISCOMFORT AND PAIN. THE SURGEON REFERRED THE PATIENT TO MR (B)(6). FOR ALLEGED ACUTE SHORTENING, PAIN AND FAILURE OF INTEGRATION. A SECOND REVISION PROCEDURE WAS PERFORMED BY MR (B)(6). ON (B)(6) 2013. THIS PI REFERS TO THE FIRST REVISION PROCEDURE PERFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495883 ABG II CUP&CERAMIC INS PK N/HL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH G2668757C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention