BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM

    MDR report key: 5003654 · Received August 14, 2015

    Report

    Report Number
    0002249697-2015-02676
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 7, 1999
    Report Date
    July 17, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDK
    PMA / PMN Number
    K965056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THE EVENT INDICATES THE HIP DISLOCATED, WHICH OCCURS WHEN THE HEAD DISLOCATES FROM THE LINER. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE REMAINING DEVICES. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 1999, A STRYKER TRIDENT ACETABULAR HIP SYSTEM CERAMIC ON CERAMIC WAS IMPLANTED IN THE PATIENT. ON OR ABOUT (B)(6) 2002, (B)(6) 2003, (B)(6) 2003 AND (B)(6) 2003, THE PATIENT ALLEGEDLY SUFFERED REPEATED DISLOCATIONS OF THE LEFT HIP, LAX GAIT. ON OR ABOUT (B)(6) 2003, THE PATIENT ALLEGEDLY UNDERWENT REVISION SURGERY OF THE LEFT TRIDENT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON OR ABOUT (B)(6) 1999, A STRYKER TRIDENT ACETABULAR HIP SYSTEM CERAMIC ON CERAMIC WAS IMPLANTED IN THE PATIENT. ON OR ABOUT (B)(6) 2002, (B)(6) 2003, THE PATIENT ALLEGEDLY SUFFERED REPEATED DISLOCATIONS OF THE LEFT HIP, LAX GAIT. ON OR ABOUT (B)(6) 2003, THE PATIENT ALLEGEDLY UNDERWENT REVISION SURGERY OF THE LEFT TRIDENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540107 SECUR-FIT HA PSL CUP/CLUSTR SHELL 52MM IMPLANT JDK STRYKER ORTHOPAEDICS-MAHWAH 40491401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R