BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +12 BLK

    MDR report key: 4220722 · Received November 3, 2014

    Report

    Report Number
    1818910-2014-30997
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    August 7, 2009
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - PATIENT REVISED FOR DISLOCATION DUE TO CUP POSITIONING. DOI (B)(6) 2009, DOR (B)(6) 2009 ( RIGHT HIP). UPDATE LITIGATION PAPERS RECEIVED. NO NEW INFORMATION RECEIVED. UPDATE REC'D 3/28/2013- PPD AND MEDICAL. RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FROM (B)(6) 2009 INDICATED DISLOCATION, INSTABILITY, OSTEOLYSIS, AND SYNOVITIS. THERE WAS NO MENTION OF A MALPOSITIONED CUP AS INDICATED IN LITIGATION. THE MDR DECISION FOR THE LINER IS BEING CHANGED TO REPORTABLE FOR THE OSTEOLYSIS AND DISLOCATION. THE PATIENT WENT THROUGH ANOTHER REVISION ON (B)(6) 2012 THAT INDICATED A LOOSE AND MALPOSITIONED CUP/SCREWS. THE PART/LOT FOR THE 1ST SCREW REPORTED IS BEING CORRECTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 11/3/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701779 ARTICUL/EZE BALL 28 +12 BLK HIP FEMORAL HEAD LPH DEPUY INTL., LTD. ¿ REG. # 8010379 1928083

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention