BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 3103242 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16835
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 5, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 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. THIS COMPLAINT IS CONSIDERED COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.ADDITIONAL INFORMATION IN F10. THIS COMPLAINT IS CONSIDERED COMPLETED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PERSISTENT PAIN AND ELEVATED METAL LEVELS.

    Description of Event or Problem · 1

    UPDATE 5/5/2015- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN AND MILD SYNOVITIS. LAB RESULTS FROM (B)(6) 2012 INDICATED METAL ION LEVELS BELOW 7PPB. PART/LOT IS BEING UPDATED FOR THE STEM. THE COMPLAINT WAS UPDATED ON:5/26/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203629 PINNACLE MTL INS NEUT36IDX52OD ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC. 1818910 2175627

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention