BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 2122756 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-08552
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    AT THE REQUEST OF THE DEPUY LEGAL TEAM THESE DEVICES WERE RETURNED TO THE SURGEON PRIOR ANY PHYSICAL EXAMINATION HAVING BEEN PERFORMED BY DEPUY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. 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

    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

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES CONSTRAINED LINER, DISLOCATION, METAL WEAR AND METALLOSIS. REVISION NOTES REPORTED THAT THERE WERE CONSIDERABLE METALLOSIS AND BLACKENING OF THE GREATER TROCHANTERIC BURSA AND A VERY MILKY GRAYISH FLUID WAS EXPRESSED FROM WITHIN THE CAPSULE WHICH HAD COMMUNICATED WITH THE GREATER TROCHANTERIC BURSA.

    Description of Event or Problem · 1

    PATIENT REVISED FOR INSTABILITY AND A.L.V.A.L. DOI: (B)(6) 2007, DOR 5/6/2011. RETURN PRODUCTS TO SALES REP/DR/PATIENT. UPDATE 5/4/2012 - LITIGATION PAPERS RECEIVED. THEY ALLEGE THAT PATIENT EXPERIENCED PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, AND HIGH LEVELS OF TOXIC METAL IN HER BLOOD STREAM. THIS INFORMATION DOES NOT AFFECT THE INVESTIGATION. UPDATE AD 07 MAY 2018: WPC 5460-2011 HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES CONSTRAINED LINER, DISLOCATION, METAL WEAR AND METALLOSIS. REVISION NOTES REPORTED THAT THERE WERE CONSIDERABLE METALLOSIS AND BLACKENING OF THE GREATER TROCHANTERIC BURSA AND A VERY MILKY GRAYISH FLUID WAS EXPRESSED FROM WITHIN THE CAPSULE WHICH HAD COMMUNICATED WITH THE GREATER TROCHANTERIC BURSA. ADDED PATIENT'S DOB, LAWYER, FACILITY NAME, PATIENT HARMS, MEDICAL HISTORY, EXPIRATION DATE OF HEAD AND LINER AND UPDATED PATIENT'S INITIALS. ADDED STEM DUE TO THE ALLEGED ELEVATED METAL IONS, AND ADDED CUP DUE TO ITS REVISION. AFTER THE FIRST REVISION, PPF ALLEGES ELEVATED METAL IONS, HOWEVER, THE NEWLY IMPLANTED HEAD WAS NON-METAL, LINER WAS NON-DEPUY AND STEM WAS ALREADY REPORTED. DOI: (B)(6) 2007 - DOR: MAY 6, 2011 (LEFT HIP).

    Description of Event or Problem · 1

    PATIENT REVISED FOR INSTABILITY AND A.L.V.A.L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM +8.5 87 JDI, LPH JDI DEPUY ORTHOPAEDICS, INC. 1818910 NA 2312378

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention