BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +5

    MDR report key: 3834247 · Received May 28, 2014

    Report

    Report Number
    1818910-2014-19565
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    March 7, 2006
    Report Date
    September 13, 2012
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    PFS AND MEDICAL RECORDS RECEIVED. PATIENT ALLEGES PAIN AFTER HER RIGHT HIP REPLACEMENT. THE HEAD AND LINER ARE BEING REPORTED. A DOR WAS REPORTED, BUT THERE ARE NO MEDICAL RECORDS TO SUPPORT THIS. IF WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED. DOI: (B)(6) 2006 DOR: (B)(6) 2007 (REPORTED, BUT NO MEDICAL RECORDS) RIGHT HIP PT IS A RESIDENT OF (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (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

    PFS AND MEDICAL RECORDS RECEIVED. PATIENT ALLEGES PAIN AFTER HER RIGHT HIP REPLACEMENT. THE HEAD AND LINER ARE BEING REPORTED. A DOR WAS REPORTED, BUT THERE ARE NO MEDICAL RECORDS TO SUPPORT THIS. IF WE RECEIVE MORE INFORMATION WE WILL UPDATE AS NEEDED.

    Description of Event or Problem · 1

    UPDATE 18 APR 2018. PINNACLE PPF, LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, A LIMP, AND LIMITED MOBILITY. PPF HAS NO NEW ALLEGATIONS. AFTER THE REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION ADDED THAT WILL CHANGE THE MDR REPORTABILITY. DOI: (B)(6) 2006; DOR: (B)(6) 2007; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313470 ARTICULEZE M HEAD 36MM +5 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDIC INC, 1818910 1991921

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other