BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML STEM

    MDR report key: 1772275 · Received July 22, 2010

    Report

    Report Number
    1818910-2010-04900
    Event Type
    Injury
    Date Received
    July 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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

    (B)(4) REPORTS: PATIENT WITH PAIN IN RIGHT HIP. SINCE (B)(6) 2009 WALKS SUPPORTED BY A WALKING STICK AND WITH DIFFICULTIES TO GET UP. HE WAS IMPLANTED IN HOSPITAL (B)(6) WITH RIGHT HIP TOTAL PROSTHESIS, AML STEM FIVE YEARS AGO. HE WAS DIAGNOSED AS HAVING STEM BREAKAGE IN OTHER HOSPITAL AND HE WAS TRANSFERRED TO HOSPITAL (B)(6) WHERE THIS STEM WAS EXPLANTED. EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED EVENT. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE 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 WITH PAIN IN RIGHT HIP. HE WAS DIAGNOSED AS HAVING STEM BREAKAGE IN OTHER HOSPITAL AND HE WAS TRANSFERRED TO HOSPITAL (B)(6) WHERE THIS STEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML STEM STEM LPH DEPUY ORTHOPAEDICS, INC. NA YK4AR1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention