BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3884868 · Received June 19, 2014

    Report

    Report Number
    1818910-2014-21522
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    January 9, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE REC'D 9/12/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DIFFICULTY AMBULATING, METALLOSIS, FLUID COLLECTION AROUND THE TROCHANTER AND GLUTEAL AREA, PSEUDOTUMOR AND SYNOVECTOMY. PART/LOT HAS BEEN PROVIDED. 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

    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.

    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.

    Additional Manufacturer Narrative · 1

    PATIENT HAD A LEFT TOTAL HIP DONE IN 2006 WITH A PINNACLE CUP AND SUMMIT STEM WITH METAL ON METAL HEAD AND LINER. DUE TO PAIN, THE METAL LINER AND HEAD WERE REMOVED (IMPLANTS SENT TO RISK MANAGEMENT). THE NECK OF THE STEM SHOWED METAL CORROSION AS WELL AS THE BACKSIDE OF THE METAL LINER. A POLY LINER AND TS CERAMIC HEAD WERE INSERTED. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THE PROVIDED PRODUCT AND LOT COMBINATION. A DHR REVIEW OR LOT SPECIFIC DATABASE SEARCH WAS NOT POSSIBLE FOR THE ADDITIONAL PRODUCT ASSOCIATED WITH THIS REPORT AS LOT CODE(S) WAS NOT PROVIDED. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. 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. 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

    UPDATE 1/9/15 - PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED CORROSION ON THE TAPER AND BEHIND THE LINER. LAB RESULTS FROM (B)(6) 2013 INDICATED THE METAL ION LEVELS WERE ABOVE 7 PPB. THERE WAS NO MENTION METALLOSIS OR PSEUDOTUMOR AS PREVIOUSLY ALLEGED. THE COMPLAINT WAS UPDATED ON:2/5/2015.

    Description of Event or Problem · 1

    PATIENT HAD A LEFT TOTAL HIP DONE IN 2006 WITH A PINNACLE CUP AND SUMMIT STEM WITH METAL ON METAL HEAD AND LINER. DUE TO PAIN, THE METAL LINER AND HEAD WERE REMOVED (IMPLANTS SENT TO RISK MANAGEMENT). THE NECK OF THE STEM SHOWED METAL CORROSION AS WELL AS THE BACKSIDE OF THE METAL LINER. A POLY LINER AND TS CERAMIC HEAD WERE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359869 ARTICULEZE M HEAD 36MM +1.5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2159225

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention