BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP 52MM

    MDR report key: 7482301 · Received May 3, 2018

    Report

    Report Number
    3005975929-2018-00142
    Event Type
    Injury
    Date Received
    May 3, 2018
    Date of Event
    February 16, 2017
    Report Date
    July 24, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502575
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS AND METALLOSIS. DURING THE REVISION THE HEMI HEAD, MODULAR SLEEVE AND BHR CUP WERE REMOVED. THE FEMORAL STEM REMAINS IMPLANTED. 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 DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. REVIEW OF THE PROVIDED IMPLANTATION REPORT DID NOT REVEAL ANY INCONSISTENCIES RELATED TO THE SURGICAL TECHNIQUE THAT COULD EXPLAIN THE LATER REVISION. ONLY A DISCHARGE REPORT WAS PROVIDED WITHOUT INFORMATION REGARDING THE ALLEGED BLOOD METAL IONS AND METALLOSIS. WITHOUT ANY INFORMATION TO DETERMINE A ROOT CAUSE OR INFORMATION THAT FURTHER EXPLAINED THE CIRCUMSTANCES LEADING TO THE REVISION, FURTHER ASSESSMENT IS NOT POSSIBLE. 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 · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [192666 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO ELEVATED METAL ION LEVELS AND METALLOSIS. BILATERAL PATIENT, SEE MDR 3005975929-2018-00140 FOR RIGHT SIDE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327601 BHR ACETABULAR CUP 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 089480 03596010502575

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R FEMORAL STEM, # 71309015, LOT # 08FM02468A| HEMI HEAD, # 74122546, LOT # 08GW18083| MODULAR SLEEVE, # 74222400, LOT # 08BW15731| FEMORAL STEM, # 71309015, LOT # 08FM02468A| HEMI HEAD, # 74122546, LOT # 08GW18083| MODULAR SLEEVE, # 74222400, LOT # 08BW15731