BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2945012 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-11926
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    August 27, 2012
    Report Date
    January 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY 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

    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

    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.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 CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    MAUDE REPORT ((B)(4)) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT HE WAS REVISED TO ADDRESS PAIN AND POSSIBLE METAL POISONING. NECROTIC TISSUE WAS REMOVED.

    Description of Event or Problem · 1

    UPDATE REC'D 4/25/2014 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS IT CONFIRMED NECROTIC TISSUE AROUND THE CUP THAT WAS CONSISTENT WITH METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE APR 12, 2018: PPF, PFS AND MEDICAL RECORDS RECEIVED. PLAINTIFF PROFILE FORM REVIEWED IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO METAL WEAR AND METALLOSIS. PFS ALLEGES METALLOSIS , METAL DEBRIS, METAL REACTION, INFLAMMATION AND TISSUE NECROSIS OF THE LEFT HIP CAUSING PAIN AND PHYSICAL RESTRICTIONS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND CONCERN ABOUT INFECTION. REVISION NOTE REPORTED, THE PATIENT WAS FOUND TO HAVE METALLOSIS WITHOUT ANY EVIDENCE OF GROSS INFECTION. THE PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF ACETABULAR LINER. IT WAS MENTIONED THAT THE CRP AND ESR BECAME ELEVATED HOWEVER THERE WERE NO LABORATORY RESULTS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50569 ARTICULEZE M HEAD 36MM +1.5 FEMORAL HEAD JDI DEPUY ORTHOPAEDIC INC, 1818910 2255262

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention