BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3636527 · Received February 20, 2014

    Report

    Report Number
    1818910-2014-12995
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 27, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    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. THE 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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2001730 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2032231 LOT CODE FOUND ONE MANUFACTURING DEVIATION. IT WAS CONFIRMED THAT THE DEVIATION SHOULD HAVE HAD NO EFFECT ON THE REPORTED COMPLAINT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR 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

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

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, SORENESS AND ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107839 PINNACLE MTL INS NEUT36IDX52OD HIP ACETABULAR INSERT/LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2001730

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention