BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AML HIGH OFFSET LG STAT 19.5MM

    MDR report key: 4943475 · Received July 27, 2015

    Report

    Report Number
    1818910-2015-26594
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 11, 2013
    Report Date
    July 16, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK012364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTS EXPERIENCING "END OF STEM" PAIN BI-LATERALLY, BUT HAS NOT YET BEEN REVISED. UPDATE 08/26/2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN AND STEM LOOSENING. UPDATE 09/25/2013- X-RAY WAS RECEIVED AND ATTACHED TO COMPLAINT. MEDICAL RECORDS WERE RECEIVED. UPDATE 09/19/2013- PER TERRITORY OFFICE, PRODUCT IS NOT BEING RETURNED. PRODUCT STATUS HAS BEEN CHANGED. UPDATE 09/25/2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION THE STEM WAS FOUND TO HAVE SCANT BONY INGROWTH IN THE FAR PROXIMAL ASPECT OF THE BODY BUT DISTALLY THERE WAS NO FIXATION. ALSO, RECORDS NOTED THAT THERE WAS NO SIGN OF METALLOSIS OR OTHER GROSS ISSUES WITH THEIR METAL ON METAL BEARING. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATE RECEIVED 5/22/14. THE SALES REP HAS REPORTED THE REVISION SURGERY FOR THE RIGHT HIP. PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC'D 7/16/15 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM ELEVATED METAL ION LEVELS, PAIN, DISCOMFORT, INFLAMMATION, AND A POPPING/SNAPPING SENSATION OF THE RIGHT HIP. THE STEM IS NOW BEING REPORTED TO ADDRESS ALLEGATIONS OF ELEVATED TOXIC METAL IONS.

    Description of Event or Problem · 1

    UPDATE 11/6/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FOR THE LEFT HIP CONFIRMED THE LOOSE STEM. THE REVISION OPERATIVE NOTE FOR THE RIGHT HIP INDICATED METALLOSIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. AT THIS TIME NO LITIGAITON HAS BEEN PROVIDED AGAINST THE LEFT HIP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON:11/6/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486025 AML HIGH OFFSET LG STAT 19.5MM HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US Z3YAF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention