BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY AML HIP STEM

    MDR report key: 3053061 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15258
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    July 29, 2015
    Report Date
    March 25, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW 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. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. UPDATE: PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS INDICATE DURING IMPLANTATION OF THE STEM THE FEMORAL NECK CRACKED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    UPDATE MAY 18, 2017: LITIGATION RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES STIFFNESS AND STABILITY PROBLEMS. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, REVISION NOTES NOTED SOME METALLOSIS BETWEEN THE LINER AND SHELL. THERE WAS NO LOOSENING OR PSEUDOTUMOR NOR LOCAL TISSUE REACTION. METAL ION LEVELS WERE BELOW 7NG/L. DURING THE IMPLANTATION ON (B)(6) 2009, IT WAS MENTIONED IN THE INTRAOPERATIVE NOTES , THAT THE SURGEON NOTED A CRACK AT THE FEMORAL NECK DURING IMPACTION OF THE AML STEM. BECAUSE OF THE CRACK IN THE MEDIAL ASPECT OF THE FEMORAL NECK, THEY THEN PLACED A 2-MM CABLE AROUND THE PROXIMAL FEMUR JUST DISTAL TO THE LESSER TROCHANTER. THIS COMPLAINT WAS UPDATED ON MAY 23, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156737 UNKNOWN DEPUY AML HIP STEM STEM KWA DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other