BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 48MM ID US COCR LNR MM60

    MDR report key: 7664580 · Received July 5, 2018

    Report

    Report Number
    3005975929-2018-00249
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    August 7, 2017
    Report Date
    June 11, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS BILATERAL COMPLAINT. IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS, ELEVATED COBALT AND CHROMIUM LEVELS, PSEUDOTUMOR AND MULTIPLE DISLOCATIONS. DURING REVISION, THE R3 LINER AND BHR RESURFACING HEAD WERE REMOVED, ALONGSIDE THE REMAINING R3 SHELL. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE KNOWN DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY WAIVERS, CONCESSIONS, MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. THE RIGHT SIDE REVISION (BOTH OCCURRED BEFORE THE LEFT REVISION) OPERATIVE NOTES DOCUMENT; ¿THERE WAS MODERATE SYNOVITIS OF THE RIGHT HIP PRESENT. THE BACKSIDE OF THE ACETABULAR METAL LINER WAS MARKED GRAIN OF SOFT TISSUE INDICATING THIS WAS THE PRIMARY AREA OF MICROMOTION AND METAL DEBRIS.¿ METAL ION LEVELS WERE PROVIDED ¿ THE FIRST SET WAS PRIOR TO THE RIGHT SIDE REVISION = COBALT: 5.0 NG/ML HIGH [<3.0] CHROMIUM: 9.1MCG/L HIGH [0.1-2.01]. THE SECOND SET WAS JUST BEFORE THE LEFT SIDE REVISION = COBALT 1.8 NG/L [<3.0] CHROMIUM: 3.7 MCG/L HIGH [0.1-2.1]. THEY WERE DEFINITELY LOWER THAN THE FIRST SET BUT STILL ELEVATED. THE CLINICAL INFORMATION PROVIDED, (C-210409 C-201410) THE ELEVATED METAL ION LEVELS, SYNOVITIS AND STAINING MAY BE CONSISTENT WITH A REACTION TO METAL DEBRIS. HOWEVER THE SOURCE CANNOT BE DETERMINED WITH THE AVAILABLE DOCUMENTATION. ALSO, IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. THE COMPONENTS REVISED WERE THE BHR RESURFACING, THE R3 LINER AND R3 SHELL. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, AND OUR INVESTIGATION REMAINS INCONCLUSIVE. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS; ELEVATED COBALT AND CHROMIUM LEVELS; PSEUDOTUMOR; MULTIPLE DISLOCATIONS. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. SINCE NEITHER THE UNDERLYING MEDICAL DOCUMENTS NOR DEVICE PART DETAILS WERE RECEIVED FOR INVESTIGATION NO THOROUGH MEDICAL INVESTIGATION, MANUFACTURING RECORD REVIEW AND ASSESSMENT OF THE REPORTED EVENT CAN BE PERFORMED. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. WITHOUT ADDITIONAL INFORMATION ABOUT THIS PATIENT'S PARTICULAR CASE, OUR INVESTIGATION REMAINS INCONCLUSIVE. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS; ELEVATED COBALT AND CHROMIUM LEVELS; PSEUDOTUMOR; MULTIPLE DISLOCATIONS. SUBSEQUENT REVISION OF UNKNOWN PARTS (B)(6) 2017. PREVIOUS MDR WAS SUBMITTED FOR THE SAME PATIENT DUE TO LEFT HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507057 R3 48MM ID US COCR LNR MM60 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD NI 08MW20523

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R 71332530/09EM20546| 71335560/09CM03190| 71336500/09GM05286| 74123148/07JW13246| UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER| UNKNOWN BHR IMPLANT/ UNKNOWN LOT NUMBER