BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +8.5

    MDR report key: 2978649 · Received February 26, 2013

    Report

    Report Number
    1818910-2013-12855
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. LITIGATION ALLEGES THAT FRICTION WEAR BETWEEN THE COBALT CHROMIUM METAL LINER AND FEMORAL HEAD HAS CAUSED PAIN, DISCOMFORT, AND DIFFICULTY AMBULATING. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP). DOI: (B)(6) 2010- DOR: NONE REPORTED (RIGHT HIP). UPDATE 05/23/2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. OPERATIVE NOTES INDICATE THAT THE PATIENT WAS IMPLANTED WITH CERAMIC ON METAL; THEREFORE, COULD NOT HAVE SUFFERED FROM THEIR PREVIOUS CLAIM OF METAL ON METAL ISSUES. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD FOR PRODUCT 121887354 LOT 3106502 DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. PROVIDED PATIENT RECORDS HAVE BEEN EXAMINED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION, IT IS UNLIKELY THAT THE COMPLAINT IS PRODUCT RELATED. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UPDATED: DATE OF BIRTH, WEIGHT, EVENT/PROBLEM DESCRIPTION, BRAND NAME, DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MANUFACTURER, PMA/510(K) #, MANUFACTURE DATE. THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT FRICTION WEAR BETWEEN THE COBALT CHROMIUM METAL LINER AND FEMORAL HEAD HAS CAUSED PAIN, DISCOMFORT, AND DIFFICULTY AMBULATING.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT FRICTION WEAR BETWEEN THE COBALT CHROMIUM METAL LINER AND FEMORAL HEAD HAS CAUSED PAIN, DISCOMFORT, AND DIFFICULTY AMBULATING. UPDATE 5/23/2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. OPERATIVE NOTES INDICATE THAT THE PATIENT WAS IMPLANTED WITH CERAMIC ON METAL; THEREFORE, COULD NOT HAVE SUFFERED FROM THEIR PREVIOUS CLAIM OF METAL ON METAL ISSUES. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82799 DELTA CER HEAD 12/14 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 3085132

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other