BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM CERAMIC LINER

    MDR report key: 1822806 · Received August 30, 2010

    Report

    Report Number
    9616680-2010-00525
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 12, 2005
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "IT WAS REPORTED BY THE PATIENT THAT HE HAD A HIP REPLACEMENT DONE ABOUT 5 YEARS AGO. PATIENT STATED EVER SINCE HIS SURGERY, HE HAS BEEN EXPERIENCING PAIN, AND HEARING A GRINDING AND CLICKING SOUND. PATIENT DID FOLLOW UP WITH HIS ORTHOPEDIC SURGEON. SURGEON DID SOME TEST AND EVERYTHING SEEMED TO BE OK. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS WERE PART OF A RECALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 36MM CERAMIC LINER IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other