BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 2113181 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08779
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 25, 2010
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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

    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 ITS RELEASE FOR DISTRIBUTION. MEDICAL RECORDS INCLUDING OPERATIVE REPORTS RECEIVED AND REVIEWED BY A DEPUY (B)(4) THE REVIEW DID NOT IDENTIFY A ROOT CAUSE FOR THE REPORT. 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

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT- PATIENT CONTACTED DEPUY TO REPORT THAT HER HIP "POPPED OUT" TWO WEEKS POST-OP. PATIENT THEN REPORTED THAT THE REASON FOR REVISION WAS MUSCLE PULLED AWAY FROM CUP. UPDATE 4/20/2011 - ADDITIONAL MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THE BURSA WAS STAINED BLACK CONSISTENT WITH METALOSIS. THE CUP WAS FOUND TO BE LOOSE WITH FIBROUS INGROWTH. THE COMPLAINT WAS REOPENED TO UPDATE THE MDR DECISION. LOT NUMBER IDENTIFIED. UPDATE 3/22/2012 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE REC¿D 9/10/2012¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS IT CONFIRMED METALLOSIS AND LOOSENING OF THE CUP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON : 05/12/2014. DOI: (B)(6) 2009 - DOR: (B)(6) 2010 (RIGHT SIDE). (B)(4). 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 REOPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY TO REPORT THAT HER HIP "POPPED OUT" TWO WEEKS POST-OP. PATIENT THEN REPORTED THAT THE REASON FOR REVISION WAS MUSCLE PULLED AWAY FROM CUP. ADDITIONAL MEDICAL RECORDS WERE RECEIVED. THE REVISION OPERATIVE REPORT INDICATES THAT THE BURSA WAS STAINED BLACK CONSISTENT WITH METALLOSIS. THE CUP WAS FOUND TO BE LOOSE WITH FIBROUS INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULEZE M HEAD 36MM -2 87JDI, 87LPH JDI DEPUY INTERNATIONAL, LTD. NA 2785492

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention