BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK TI 13.8 STD OFFSET

    MDR report key: 4853186 · Received June 18, 2015

    Report

    Report Number
    1818910-2015-23895
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    June 27, 2014
    Report Date
    November 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWL
    PMA / PMN Number
    K872878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, AND TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. UPDATE (B)(6) 201 5- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FOR THE RIGHT HIP (B)(4) INDICATED ELEVATED METAL IONS ABOVE 7 (NO DATE OR UNIT OF MEASUREMENTS PROVIDED). AN UNKNOWN STEM IS BEING ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    UPDATE ¿(B)(6) 2016 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, WITH THE EXCEPTION OF ABOUT 20 PAGES THAT WERE ILLEGIBLE, FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED THE MEDICAL RECORDS FROM (B)(6) 2014 STATED THAT THE PATIENT REPORTED HAVING INSTABILITY AND FALLING. THERE WAS NO NEW INFORMATION PROVIDED THAT WOULD AFFECT THE EXISTING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396759 TRI-LOCK TI 13.8 STD OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM KWL DEPUY ORTHOPAEDICS INC US B34DY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other