BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+1.5

    MDR report key: 3870428 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20893
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    November 17, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION IN F10. 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

    (B)(4) - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM NECROSIS.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

    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

    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

    PATIENT WAS REVISED TO METAL ON METAL REACTIONS, ADDRESS ELEVATED METAL ION LEVELS AND PROGRESSIVE OSTEOLYTIC CHANGES. UPDATE REC'D 06/09/2014 - PATIENT CLAIM RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, CLAIM STATES THE PATIENT SUFFERS FROM SCALLOPING OF THE MEDICAL CALCAR AND PAIN. DOI: (B)(6) 2008 - DOR: (B)(6) 2014 (RIGHT HIP). UPDATE REC'D 07/14/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM NECROSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. PER WI-3430, A REVIEW OF THE DEVICE HISTORY RECORDS IS NO LONGER REQUIRED FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. 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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO METAL ON METAL REACTIONS, ADDRESS ELEVATED METAL ION LEVELS AND PROGRESSIVE OSTEOLYTIC CHANGES.

    Description of Event or Problem · 1

    UPDATE 11/17/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED OSTEOLYSIS, METAL SENSITIVITY, CORROSION ON THE TRUNNION, AND ELEVATED METAL IONS LEVELS. THE LEVELS THEY GAVE FOR THE COBALT AND CHROMIUM LEVELS WERE BOTH BELOW 7PPB. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Description of Event or Problem · 1

    UPDATE REC'D 9/24/14 - USER FACILITY MEDWATCH MW5037337 RECEIVED. METAL ON METAL DEPUY RIGHT REPLACEMENT HIP IMPLANTED (B)(6), 2008 DUE TO OSTEOARTHRITIS. IN LATE 2011 A SMALL AREA OF SCALLOPING AND LYSIS WAS DETECTED UNDER THE COLLAR OF THE FEMORAL PROSTHESIS WHICH PROGRESSED YEARLY. LAB IN (B)(6) 2013 REVEALED INCREASED COBALT LEVELS. I UNDERWENT A REVISION SURGERY ON (B)(6) 2014. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348103 12/14 ARTICUL 40MM M SPEC+1.5 HIP FEMORAL HEAD LPH DEPUY INTERNATIONAL LTD.-8010379 2353416

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention