BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT PSL HA SOLID BACK 54MM

    MDR report key: 2063374 · Received April 13, 2011

    Report

    Report Number
    9616680-2011-00203
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR.# 9616680-2011-00204, 9616680-2011-00205.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCTS FAILED INTRA-OPERATIVELY AND REPLACEMENT IMPLANTS WERE USED TO COMPLETE THE SURGERY. SALES REP ADDED THAT THE PRODUCTS APPEAR COMPATIBLE AND THEY FIT CORRECTLY. SALES REP FURTHER ADDED THAT HE THINKS THAT THEY WERE PLACED SKEWED WHICH IS THE REASON WHY THEY JAMMED. SALES REP FURTHER REPORTED THAT IT DOES NOT APPEAR AS THOUGH THERE IS A DEFECT WITH THE IMPLANT ITSELF. NO ADVERSE CONSEQUENCES WERE REPORTED. A LESS THAN 30 MINUTES DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT PSL HA SOLID BACK 54MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35602301

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other