BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2111444 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08173
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    DEPUY INTL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: PATIENT WAS REVISED. SURGEON STATES REASON FOR REVISION: MODERATE TRUNNION WEAR AND SYNOVITIS. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (LEFT SIDE). UPDATE: FOLLOW-UP WAS COMPLETED TO CLARIFY THE COMPLAINT DESCRIPTION. CORROSION WAS FOUND ON THE TRUNNION OF THE STEM. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION FOR CORROSION OR SYNOVITIS. A REVIEW OF THE 1012-14-030 TRI-LOCK STEM DEVICE HISTORY RECORDS AND MATERIAL CERTIFICATIONS DID NOT IDENTIFY ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION CAN DRAW NO CONCLUSION FROM THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED. SURGEON STATES REASON FOR REVISION: MODERATE TRUNNION WEAR AND SYNOVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 87KWA KWA DEPUY INTL, LTD. NA 2708207

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention