BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 2122741 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09864
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    November 10, 2010
    Report Date
    May 5, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES ASSOCIATED WITH THIS REPORT HAVE BEEN RETURNED FOR EXAMINATION. 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

    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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS ON-GOING INFECTION. UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE, PT HAS SUFFERED AND CONTINUES TO SUFFER BOTH INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO: PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; AND PAST, PRESENT AND FUTURE MEDICAL, HOSPITAL, REHABILITATIVE AND PHARMACEUTICAL EXPENSES, LOST WAGES, AND OTHER RELATED DAMAGES. IT IS ALSO ALLEGED PT'S INJURIES NECESSITATED A REVISIONARY SURGERY OF THE RIGHT HIP ON (B)(6) 2010.

    Description of Event or Problem · 1

    UPDATE 6/8/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS CONFIRMED AN INFECTION. A HOLE ELIMINATOR IS BEING ADDED TO THE COMPLAINT AS IT WAS ALSO REMOVED ON (B)(6) 2010. THE PATIENT WAS REIMPLANTED ON (B)(6) 2011 WITH DEPUY PRODUCTS. THE COMPLAINT WAS UPDATED ON:7/6/2015.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention NA.