BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML SM STATURE 15.0MM

    MDR report key: 2213965 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14605
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    June 16, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K012364
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REVISED DUE TO PAIN. DOI: (B)(6) 2009 DOR: (B)(6) 2011 (LEFT SIDE). UPDATE (B)(4) 2011 - LITIGATION PAPERS ALLEGE AFTER THE SURGERY, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THIS MATTER IS IN LITIGATION. FOLLOW-UP ACTIVITIES ARE BEING PERFORMED BY THE DEPUY LEGAL TEAM. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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 THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UDI:(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED. 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

    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

    PT REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    ON JUN 16, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT HIP ARTHROPLASTY WITH A LOOSE FEMORAL COMPONENT. REVISION NOTE STATED, THERE WAS A MINIMAL FLUID ENCOUNTERED UPON EXPOSURE OF THE HIP JOINT. THERE WAS NO SIGN OF INFECTION. FEMORAL COMPONENT WAS INSPECTED AND FOUND TO BE LOOSE. THERE WAS NO SIGNIFICANT LYTIC OR OTHER BONY EROSIONS OR LOSS. THERE WAS NO SIGN OF A METAL-ON-METAL REACTION. NO PSEUDOTUMOR WAS EVIDENT. THERE WAS NO LABORATORY VALUES PROVIDED. ADDED COMPLAINANT INFORMATION AND UPDATE ALL THE PRODUCT INFORMATION. THIS COMPLAINT WAS UPDATED ON: JUN 28, 2017.

    Description of Event or Problem · 1

    PPF ALLEGES LOOSENING OF STEM. ADDED LAWYER AND LAW FIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AML SM STATURE 15.0MM AML IMPLANT : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA DD2F81000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention