BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) HEAD

    MDR report key: 14322601 · Received May 7, 2022

    Report

    Report Number
    3005975929-2022-00234
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    August 9, 2019
    Report Date
    July 11, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ILO, K. C., ABOELMAGD, K., HOTHI, H. S., ASAAD, A., SKINNER, J. A., & HART, A. J. (2021). DOES MODULARITY OF METAL-ON-METAL HIP IMPLANTS INCREASE COBALT: CHROMIUM RATIO?. HIP INTERNATIONAL, 31(1), 109-114. DOI: 10.1177/1120700019873637.

    Additional Manufacturer Narrative · 0

    SECTION H10: IT WAS REPORTED THAT ON LITERATURE REVIEW "DOES MODULARITY OF METAL-ON-METAL HIP IMPLANTS INCREASE COBALT: CHROMIUM RATIO?", BLOOD METAL IONS LEVELS WERE TAKE TO ALL 414 PATIENTS THAT HAD BHR. THE COBALT MEAN WAS OF 19 PPB (MIN 0 PPB, MAX 250 PPB) AND CHROMIUM MEAN WAS OF 16 PPB (MIN 0.3 PPB, MAX 343 PPB), IT IS UNKNOWN THE EXACT QUANTITY OF PATIENTS THAT HAD MORE LEVELS THAN ACCEPTABLE AND HOW THIS WAS ADDRESSED. FURTHER INFORMATION IS UNKNOWN AND 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. 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. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4) SECTION H6 (HEALTH EFFECTS) WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "DOES MODULARITY OF METAL-ON-METAL HIP IMPLANTS INCREASE COBALT: CHROMIUM RATIO?", BLOOD METAL IONS LEVELS WERE TAKE TO ALL 414 PATIENTS THAT HAD BHR. THE COBALT MEAN WAS OF 19 PPB (MIN 0 PPB, MAX 250 PPB) AND CHROMIUM MEAN WAS OF 16 PPB (MIN 0.3 PPB, MAX 343 PPB), IT IS UNKNOWN THE EXACT QUANTITY OF PATIENTS THAT HAD MORE LEVELS THAN ACCEPTABLE AND HOW THIS WAS ADDRESSED. FURTHER INFORMATION IS NOT KNOWN FOR THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352798 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