BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD

    MDR report key: 14743765 · Received June 20, 2022

    Report

    Report Number
    3005975929-2022-00403
    Event Type
    Injury
    Date Received
    June 20, 2022
    Date of Event
    July 21, 2021
    Report Date
    July 18, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). SU, E. P., HO, H., BHAL, V., HOUSMAN, L. R., MASONIS, J. L., NOBLE JR, J. W., & ENGH JR, C. A. (2021). RESULTS OF THE FIRST US FDA-APPROVED HIP RESURFACING DEVICE AT 10-YEAR FOLLOW-UP. JBJS, 103(14), 1303-1311. DOI: 10.2106/JBJS.20.01886.

    Additional Manufacturer Narrative · 0

    H3, H6. IT WAS REPORTED THAT, ON LITERATURE REVIEW "RESULTS OF THE FIRST U.S FDA - APPROVED HIP RESUFACING DEVICE AT TEN - YEAR FOLLOW - UP.", THE NUMBER OF PATIENTS WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION OF A BHR RESURFACING CONSTRUCT AND THAT EXPERIENCED POST-OPERATIVE COBALT AND/OR CHROMIUM LEVELS IN BLOOD GREATER THAN SEVEN PARTS PER BILLION REMAINED SIMILAR OVER TIME: SEVEN OUT OF TWO HUNDRED FIVE SHOWED EVIDENCE OF THESE LEVELS AT ONE YEAR AFTER THE INITIAL SURGERY, AND NINE PATIENTS OUT OF TWO HUNDRED FOUR SHOWED EVIDENCE DURING THE TEN POST-OPERATIVE YEAR FOLLOW UP. ALTHOUGH IT IS UNKNOWN HOW THIS EVENT WAS ADDRESSED ON EACH PATIENT, A REVISION SURGERY WAS NOT REQUIRED. THEREFORE THE DEVICES, USED IN TREATMENT, WERE NOT AVAILABLE FOR ANALYSIS. AS NO DEVICE PART AND BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW, DEVICE LABELLING / IFU REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. A REVIEW OF HISTORIC ESCALATION ACTIONS RELATED TO THE PRODUCTS AND SIMILAR COMPLAINT EVENTS WAS PERFORMED. FOLLOWING THE REVIEW, PRIOR APPLICABLE ESCALATION ACTIONS WERE IDENTIFIED AND CONFIRMED TO REDUCE ASSOCIATED RISKS AS FAR AS POSSIBLE. NO FURTHER ESCALATION ACTIONS ARE REQUIRED. A RISK MANAGEMENT REVIEW WAS PERFORMED FOR THE ACETABULAR CUP AND FEMORAL HEAD. THE ALLEGED FAILURE MODES AND ASSOCIATED RISKS HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE THE DETAILS SUPPLIED IN THIS COMPLAINT, OUR INVESTIGATION REMAINS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO SPECULATE ON SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT. 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

    IT WAS REPORTED THAT, ON LITERATURE REVIEW "RESULTS OF THE FIRST U.S FDA-APPROVED HIP RESUFACING DEVICE AT 10 YEAR FOLLOW-UP.", THE NUMBER OF PATIENTS WHO INITIALLY UNDERWENT PRIMARY IMPLANTATION OF A BHR RESURFACING CONSTRUCT AND THAT EXPERIENCED POST-OPERATIVE COBALT AND/OR CHROMIUM LEVELS IN BLOOD GREATER THAN SEVEN (7) PARTS PER BILLION REMAINED SIMILAR OVER TIME: SEVEN (7) OUT OF TWO HUNDRED FIVE (205) SHOWED EVIDENCE OF THESE LEVELS AT ONE (1) YEAR AFTER THE INITIAL SURGERY, AND NINE (9) PATIENTS OUT OF TWO HUNDRED FOUR (204) SHOWED EVIDENCE DURING THE TEN (10) POST-OPERATIVE YEAR FOLLOW UP. ALTHOUGH IT IS UNKNOWN HOW THIS EVENT WAS ADDRESSED ON EACH PATIENT, A REVISION SURGERY WAS NOT REQUIRED. FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794872 UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention