BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) IMPL

    MDR report key: 19706772 · Received July 9, 2024

    Report

    Report Number
    3005975929-2024-00115
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    March 21, 2017
    Report Date
    July 9, 2024
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: MORONI A, MISCIONE MT, ORSINI R, MICERA G, MOSCA S, SINAPI F, DE GIROLAMO L, BANFI G. CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE. HIP INT. 2017 MAR 31;27(2):134-139. DOI: 10.5301/HIPINT.5000424. EPUB 2017 MAR 21. PMID: 28362050. H10: INTERNAL REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW ""CLINICAL AND RADIOGRAPHIC OUTCOMES OF THE BIRMINGHAM HIP RESURFACING ARTHROPLASTY AT A MINIMUM FOLLOW-UP OF 10 YEARS: RESULTS FROM AN INDEPENDENT CENTRE"", 1 (ONE) PATIENT SUFFERED FROM PERIACETABULAR BONE RAREFACTION AND ELEVATED METAL ION LEVELS IN BLOOD AFTER A PRIMARY METAL-ON-METAL HIP RESURFACING PROCEDURE. HIP SCAN FOUND FLUID IN THE JOINT. TEST RESULTS INDICATED COBALT CONTENT OF 2.28 NG/ML AND CHROMIUM CONTENT OF 4.89 NG/ML. A REVISION SURGERY WAS RECOMMENDED TO ADDRESS THE ISSUE, BUT THE PATIENT REFUSED IT. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565057 UNKN BIRMINGHAM HIP RESURFACING (BHR) IMPL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other