BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 52MM

    MDR report key: 3875114 · Received June 16, 2014

    Report

    Report Number
    0002249697-2014-02287
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    TOTAL HIP REVISION SURGERY. PATIENT WAS SAID TO HAVE FALLEN AND HAD A FRACTURE IN PELVIS REGION. THE CUP THAT WAS IMPLANT IN 2012 HAD DISLOCATED FROM THE ACETABULAR SOCKET. PATIENT ALSO HAD A REJUVENATE STEM IMPLANT DURING PRIMARY SURGERY SO SURGEON DECIDED TO REVISE THE STEM AS WELL. HE REPLACED IT WITH A SECURFIT MAX STEM AND REPLACED THE PSL CUP WITH A TRITANIUM MULTIHOLE REVISION CUP.

    Description of Event or Problem · 1

    TOTAL HIP REVISION SURGERY. PATIENT WAS SAID TO HAVE FALLEN AND HAD A FRACTURE IN PELVIS REGION. THE CUP THAT WAS IMPLANT IN 2012 HAD DISLOCATED FROM THE ACETABULAR SOCKET. PATIENT ALSO HAD A REJUVENATE STEM IMPLANT DURING PRIMARY SURGERY SO SURGEON DECIDED TO REVISE THE STEM AS WELL. HE REPLACED IT WITH A SECURFIT MAX STEM AND REPLACED THE PSL CUP WITH A TRITANIUM MULTIHOLE REVISION CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352078 TRIDENT PSL HA CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MLA6LH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R