BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECLAIM HEAD SIZE 13

    MDR report key: 2875371 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83826
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    MNI
    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. ADDITIONAL EVENT INFORMATION WAS REQUESTED BUT NOT PROVIDED TO CUSTOMER QUALITY. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH USING AS400 AND JDE INDICATES SEVERAL OTHER DEVICES FROM THE REPORTED LOTS HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO RECURRENT DISLOCATION. THE PRIMARY IMPLANT WAS APPROXIMATELY 6 WEEKS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECLAIM HEAD SIZE 13 DEPUY HIP IMPLANT MNI DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention