BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR ACETABULAR CUP 52MM

    MDR report key: 8144910 · Received December 8, 2018

    Report

    Report Number
    3005975929-2018-00531
    Event Type
    Injury
    Date Received
    December 8, 2018
    Date of Event
    October 23, 2017
    Report Date
    November 21, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH CORRECTED. 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: [222363 SUMMARY.PDF]

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE BHR HEAD AND BHR CUP WERE REMOVED. 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. THIS IS A 64 YEAR OLD FEMALE WITH BILATERAL HIP PROSTHESIS FROM AUSTRALIA, DIAGNOSED WITH METALLOSIS. ON 7-29-2015, CHROMIUM=0.07¿MOL/L (REF RANGE=0.10) [3.64¿G/L] AND COBALT=0.11¿MOL/L (REF RANGE=0.02) [6.49¿G/L]. OPERATIVE DETAILS: POSTERIOR APPROACH ¿ ¿TYPICAL METALLOSIS WHITE FLUID AND 2 X SACS WITH THICKENED WALL, NO MACROSCOPIC WEAR¿. AFTER THE REVISION SURGERY, DURING WHICH ALL SMITH & NEPHEW DEVICES WERE REPLACED WITH COMPETITOR DEVICES, THIS PATIENT EXPERIENCED SEVERAL WASHOUTS AND REVISIONS SECONDARY TO STAPH AUREUS/SEPSIS, PRESUMED DUE TO HER IMMUNOSUPPRESSED STATE SECONDARY TO STEROID USE FOR SEVERAL YEARS FOR A CONNECTIVE TISSUE DISORDER. SHE WAS HOSPITALIZED FOR APPROXIMATELY 2 MONTHS. THE CLINICAL INFORMATION PROVIDED, OF THE MILDLY ELEVATED METAL ION LEVELS AND THE PSEUDOTUMOUR MAY BE CONSISTENT WITH A REACTION TO METAL DEBRIS. HOWEVER THE SOURCE CANNOT BE DETERMINED WITH THE AVAILABLE DOCUMENTATION. THE INFECTIONS AND SUBSEQUENT ISSUES COULD BE ATTRIBUTED TO HER SEVERE IMMUNOSUPPRESSED STATE SECONDARY TO STEROIDS AND DOCUMENTED CONNECTIVE TISSUE DISORDER. 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.

    Description of Event or Problem · 0

    EXCISION OF PSEUDOTUMORS DURING REVISION SURGEY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984341 BHR ACETABULAR CUP 52MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 07HW13117 03596010502575

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 74123144/ FEMORAL HEAD 44MM/ 07HW13411| FEMORAL HEAD, #74123144, LOT # UNKNOWN