BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 3971478 · Received July 31, 2014

    Report

    Report Number
    1818910-2014-24691
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INFORMATION PROVIDED IDENTIFIED THAT INSUFFICIENT INFORMATION HAD BEEN RECEIVED TO VERIFY THE REPORTED INCIDENT OR COMPLETE A COMPLAINT INVESTIGATION.THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE PROVIDED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE INITIAL THA WAS CONDUCTED ON (B)(6) 2008. THE PATIENT WAS SUSPECTED TO HAVE DEVELOPED ALVAL, THUS THE REVISION WAS OPERATED ON (B)(6) 2014. DURING THE SURGERY, THE SURGEON FOUND THAT ONE OF THE THREE DOME SCREWS USED WAS FRACTURED. HE ALSO FOUND THAT THE CUP WAS LOOSE, AND THE EDGE SEEMED TO BE SCRATCHED WITH THE SCREW. FURTHERMORE, BLACKENED SOFT TISSUES WERE SURROUNDING THE STEM NECK. THE SURGEON REPLACED THE CUP, THE STEM AND THE HEAD, BUT THE DISTAL TIP OF THE FRACTURED SCREW AND THE SLEEVE WAS KEPT REMAINED. THE SURGEON WAS UNCERTAIN WHETHER THE SCRATCH ON THE EDGE OF THE CUP CAUSED THE LYSIS, OR THE ALVAL WAS THE CAUSE. THE COMPLAINED PRODUCTS ARE NOT AVAILABLE FOR THE EVALUATION FOR THE SURGEON WISH TO KEEP THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448482 UNKNOWN CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention