BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3801597 · Received May 9, 2014

    Report

    Report Number
    3005477969-2014-00310
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 21, 2012
    Report Date
    May 9, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REOPENED COMPLAINT DUE TO RECEIPT FURTHER INFORMATION. IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED. PHYSICAL INJURIES, PAIN, METALLOSIS, SWELLING, INFLAMMATION, DIFFICULTY STANDING & WALKING, GAIT ISSUES AND LACK OF MOBILITY REPORTED. THE FEMORAL HEAD AND BHR CUP WERE REVISED DURING SURGERY. AS OF TODAY, NO 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 DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. DEVICE HISTORY RECORD REVIEW CONFIRMED THAT ALL RELEASED PARTS MET SPECIFICATIONS APPLICABLE AT THE TIME OF PRODUCTION. THE PROVIDED MEDICAL DOCUMENTS HAVE BEEN REVIEWED. ACCORDING TO THE PROVIDED IMPLANTATION REPORT, IT WAS REAMED TO 58 MM AND A 58 MM CUP WAS IMPLANTED. ACCORDING TO THE SURGICAL TECHNIQUE (LIT. NO 10/10 REV A 4567-0103), IT SHOULD BE REAMED TO 1 TO 3 MM SMALLER THAN THE CUP SIZE. BASED ON THE PROVIDED REVISION REPORT, THE COMPONENTS WERE STABLE, THERE WAS BROWNISH AND HEMOSIDERIN STAINING OF THE TISSUES, A SMALL FLUID COLLECTION ON THE GREATER TROCHANTER AND INTO THE JOINT AND THERE WERE NO OBVIOUS METAL CONTAMINATION. NO REPORT OF METAL IONS WAS PROVIDED. NO PATHOLOGY REPORT WAS PROVIDED TO CONFIRM THE REPORTED METALLOSIS WERE PROVIDED. WHETHER THE SIZE OF THE LAST REAMER HAD AN IMPACT ON THE INITIAL FIXATION CANNOT BE DETERMINED WITH THE LIMITED DOCUMENTS AVAILABLE. IT WAS REPORTED THAT THE PATIENT HAD A FEW DISLOCATIONS AND SUFFERED FROM ALCOHOLISM. THE PROVIDED DOCUMENTS DID NOT CONTAIN ANY INFORMATION REGARDING THESE TWO ISSUED. DISLOCATIONS MAY HAVE AN ADVERSE EFFECT ON THE INTEGRITY OF THE BEARING SURFACES. BASED ON THE AVAILABLE DOCUMENTATION, THE NATURE OF THE REPORTED FINDINGS FROM THE REVISION REMAINS UNCLEAR, AS NO ADDITIONAL INFORMATION SUCH AS A HISTOPATHOLOGICAL ANALYSIS WAS PROVIDED. THE REPORTED METALLOSIS CANNOT BE CONFIRMED. THE REASON FOR THE PAIN THAT CAUSED THE REVISION REMAINS UNCLEAR. 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 REVISION SURGERY WAS PERFORMED DUE TO DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280825 BHR ACETABULAR CUP NXT SMITH & NEPHEW 11JW34367

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R FEMORAL HEAD, # 74123152, LOT # 11KW34522