BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) IMPL

    MDR report key: 21644977 · Received March 19, 2025

    Report

    Report Number
    3005975929-2025-00016
    Event Type
    Injury
    Date Received
    March 19, 2025
    Report Date
    April 16, 2025
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). NANDRA RS, ELNAHAL WA, MAYNE A, BRASH L, MCBRYDE CW, TREACY RBC. BIRMINGHAM HIP RESURFACING AT 25 YEARS. BONE JOINT J. 2024 JUN 1;106-B(6):540-547. DOI: 10.1302/0301-620X.106B6.BJJ-2023-1064.R1. PMID: 38821495. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS). UPDATED RESULTS OF INVESTIGATION: AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT HAVE NOT BEEN RETURNED FOR EVALUATION. AS NO DEVICE PART AND BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW, OR ESCALATION ACTIONS REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A REVISION OF THE IFU ASSOCIATED TO THE ALLEGED DEVICE. HOWEVER, THE MOST RECENT IFU LISTS SEVERAL POTENTIAL ADVERSE DEVICE EFFECTS AND WARNINGS RELATED TO BHR ARTHROPLASTY. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A REVISION OF THE RISK ASSOCIATED TO THE ALLEGED DEVICE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. BASED ON THE LIMITED INFORMATION PROVIDED A CLINICAL ROOT CAUSE FOR THE PAIN AND ELEVATED METAL IONS CANNOT BE CONFIRMED. HOWEVER, THE MEDIAL WALL FRACTURE AND INCLINATION OF APPROXIMATELY 63° CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTORY FACTORS TO THE REPORTED PAIN AND ELEVATED METAL IONS. THE INCLINATION ALSO CANNOT BE CONFIRMED IF IT¿S A CHANGE OVER TIME AS WELL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT ARE EXCESSIVE PHYSICAL ACTIVITY LEVELS, UNREASONABLE STRESS ON REPLACEMENT SYSTEM, EXCESSIVE PATIENT WEIGHT, TRAUMA TO THE JOINT REPLACEMENT, LOOSENING OF COMPONENTS MAY INCREASE PRODUCTION OF WEAR PARTICLES AND ACCELERATE DAMAGE TO THE BONE. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIRMINGHAM HIP RESURFACING AT 25 YEARS", ONE (1) PATIENT AFTER A LEFT BHR HIP RESURFACING PROCEDURE THE PATIENT COMPLAINT OF PAIN DURING WALKING AND PROLONGED SITTING AND HAD ELEVATED SERUM METAL IONS (CR 438 NMOL/L, CO 552 NMOL/L). PATIENT REQUIRED REVISION SURGERY 18 YEARS AND SIX MONTHS AFTER IMPLANTATION TO AN UNCEMENTED THA WITH CERAMIC-ON-POLYETHYLENE BEARING. PATIENT´S METAL IONS ONE-YEAR POST-SURGERY REDUCED TO NORMAL LEVELS (CR 44 NMOL/L, CO 17 NMOL/L), AND REMAINS WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620276 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 41 YR Female Required Intervention| H