BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DISTAL LOCKING SCREW

    MDR report key: 1242652 · Received November 20, 2008

    Report

    Report Number
    1818910-2008-05424
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE NAIL PART AND LOT NUMBER COMBINATION. THE LAG SCREW AND DISTAL SCREW PART AND LOT INFORMATION WAS NOT PROVIDED. A REVIEW OF THE INSPECTION RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PROVIDED INFORMATION STATES THE PATIENT HAD AN ATN IMPLANTED IN 2005, SUBSEQUENTLY REMOVED AND CONVERTED TO A TOTAL HIP DUE TO HIP PAIN. PROVIDED INFORMATION MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DISTAL LOCKING SCREW TOTAL TRAUMA HWC DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention