BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY METAL LINER

    MDR report key: 2913659 · Received January 14, 2013

    Report

    Report Number
    1818910-2013-10914
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    June 14, 2012
    Report Date
    January 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. COMPLIANT TO PART (B)(4), DEPUY ORTHOPAEDICS IS PROVIDING THE FOLLOWING INFORMATION, AS DEPUY ORTHOPAEDICS DID NOT MANUFACTURE, OR IMPORT, THE FOLLOWING DEVICE(S): MANUFACTURER: MEDICO FEMORAL HIP IMPLANT(S). EVENT: THIS WAS USED IN CONJUNCTION WITH DEPUY PRODUCT IN THIS PATIENT.

    Additional Manufacturer Narrative · 1

    MAUDE REPORT ((B)(4)) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT PATIENT RECEIVED DEPUY ACETABULAR COMPONENTS ON THEIR RIGHT SIDE ON (B)(6) 2006. WITHIN A YEAR, PATIENT EXPERIENCED PAIN AND INSTABILITY IN THEIR RIGHT HIP, AND WAS SUBSEQUENTLY DIAGNOSED WITH METALLOSIS, PSEUDO-TUMOR FORMATION AND OSTEOLYSIS, AND WAS REVISED. DOI (B)(6) 2006 - DOR (B)(6) 2012 (RIGHT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY ACETABULAR DEVICE WAS IMPLANTED WITH COMPETITOR MANUFACTURED FEMORAL DEVICES. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT PATIENT RECEIVED DEPUY ACETABULAR COMPONENTS ON THEIR RIGHT SIDE ON (B)(6) 2006. WITHIN A YEAR, PATIENT EXPERIENCED PAIN AND INSTABILITY IN THEIR RIGHT HIP, AND WAS SUBSEQUENTLY DIAGNOSED WITH METALOSIS, PSEUDO-TUMOR FORMATION AND OSTEOLYSIS, AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20795 UNKNOWN DEPUY METAL LINER ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention