BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML 10.5 STD 6.3 5/8 STD 12/14

    MDR report key: 1945480 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09796
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    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

    EXAMINATION OF THE RETURNED DEVICES AND PATIENT X-RAYS BY DEPUY INTERNATIONAL CONFIRMS THE REPORTED FRACTURE. THE STEM HAS FRACTURED IN THE POROCOATED REGION ABOVE THE DISTAL THIRD CAUSING THE MINOR TROCHANTER TO BREAK. NO PRE FRACTURED X-RAYS HAVE BEEN PROVIDED SO IT WAS NOT POSSIBLE TO DETERMINE THE BIOMECHANICS RELATING TO THE IMPLANT POSITIONING. FROM INSPECTION OF THE PROVIDED X-RAYS AND IMPLANTS IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS FAILURE. A REVIEW OF DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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

    AML STEM FRACTURED SO IT WAS NECESSARY TO REPLACE IT WITH A SOLUTION STEM. THIS STEM WAS SPLIT IN HALF DUE TO THE MEDICAL JOINT LOAD, THUS BREAKING THE MINOR TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML 10.5 STD 6.3 5/8 STD 12/14 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA XJ1FN1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention