BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-LOCK TI 7.5 LAT OFFSET

    MDR report key: 4133535 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29213
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    February 20, 2007
    Report Date
    May 26, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO CHANGE TO THE PREVIOUS INVESTIGATION. NO UPDATED INVESTIGATION REQUIRED AS NO NEW INFORMATION PROVIDED TO INVESTIGATE. 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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM CLICKING, POPPING, MULTIPLE DISLOCATIONS, PAIN, DISCOMFORT, EXCESS FLUID, A PSEUDOTUMOR AND TOXIC AMOUNTS OF 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 THE REVISION OPERATIVE NOTE INDICATED A MALPOSITIONED CUP (ANTEVERTED POSITION), IMPLANT DISLOCATION, AND IMPINGEMENT BETWEEN THE CUP AND STEM. AN UNKNOWN CUP AND STEM ARE BEING ADDED TO THE COMPLAIN. THERE WAS NO MENTION OF A PSEUDOTUMOR AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Description of Event or Problem · 1

    PPF ALLEGES DISLOCATION, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. ADDED PATIENT MIDDLE INITIAL. ADDED PRODUCT DETAILS FOR AN UNKNOWN FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613293 TRI-LOCK TI 7.5 LAT OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US WY5F71004

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention