BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN LNR CON +4 10D 32IDX54OD

    MDR report key: 1034009 · Received April 25, 2008

    Report

    Report Number
    1818910-2008-01317
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K043058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE KNOWN PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION REGARDING THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION (RIGHT SIDE). DURING THE REVISION SURGERY, THE SURGEON HAD TROUBLE WITH THE SEATING OF TWO CONSTRAINED LINER LOCKING RINGS AND ENDED UP USING A STANDARD LINER INSTEAD. THE DIFFICULTY WITH THE LOCKING RINGS RESULTED IN A SURGICAL DELAY OF APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN LNR CON +4 10D 32IDX54OD 87KWZ KWZ DEPUY ORTHOPAEDICS, INC. NA AT9DD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention