BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3834194 · Received May 28, 2014

    Report

    Report Number
    1818910-2014-19546
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    August 23, 2007
    Report Date
    October 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. ADDITIONAL NARRATIVE: 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

    (B)(4). PFS AND MEDICAL RECORDS RECEIVED AND PATIENT ALLEGES HIS LEGS TIRE EASILY, CAN HEAR CLICKING, DECREASED RANGE OF MOTION, DIFFICULTY CLIMBING STAIRS, AND HE CANNOT WALK FOR LONG PERIODS OF TIME. THE PATIENT HAS BEEN REVISED. THE HEAD AND LINER ARE BEING REPORTED. IF WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED. (B)(4). 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    PFS AND MEDICAL RECORDS RECEIVED AND PATIENT ALLEGES HIS LEGS TIRE EASILY, CAN HEAR CLICKING, DECREASED RANGE OF MOTION, DIFFICULTY CLIMBING STAIRS, AND HE CANNOT WALK FOR LONG PERIODS OF TIME. THE PATIENT HAS BEEN REVISED. THE HEAD AND LINER ARE BEING REPORTED. IF WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312803 PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS KWA DEPUY ORTHOPAEDICS INC US 2415092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other