BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)

    MDR report key: 13763173 · Received March 14, 2022

    Report

    Report Number
    3005975929-2022-00061
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    September 17, 2019
    Report Date
    May 16, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THOMPSON, Z., KHOSHBIN, A., WARD, S., WADDELL, J. P., & ATREY, A. (2020). THE EARLY-TO MEDIUM-TERM RESULTS OF A HEMISPHERICAL, POROUS COATED ACETABULAR SHELL WITH MULTIPLE DIFFERENT BEARING COMBINATIONS ARE EXCELLENT WITH THE EXCEPTION OF METAL-ON-METAL. INTERNATIONAL ORTHOPAEDICS, 44(12), 2537-2543. DOI: DOI.ORG/10.1177/1120700019877389.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "MIDTERM OUTCOMES OF TOTAL HIP ARTHROPLASTY WITH A MODULAR BIRMINGHAM HEAD", FROM 9 PATIENTS THAT INITIALLY HAD EITHER A BHR-THA OR AN R3-THA PROSTHESIS CONSTRUCT IMPLANTED, AN UNSPECIFIED QUANTITY OF THEM WERE REVISED FOR SUSPECTED SOFT TISSUE REACTION AFTER A MEDIAN OF 68 MONTHS POSTOPERATIVELY. OF THESE, 5 HAD SOFT TISSUE ABNORMALITIES, MEAN SERUM CHROMIUM LEVEL WAS 5.7 G/L AND SERUM COBALT WAS 8.1 G/L, WHILE MEAN SERUM TITANIUM WAS 2.0 G/L. NO FURTHER INFORMATION IS AVAILABLE IN REGARDS OF THE IDENTITY OF THE EXPLANTED DEVICES DURING THE REVISION SURGERY. 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. BMHR HAVE BEEN PHASED OUT FROM THE MARKET AND AS A RESULT THERE IS NO LIVE RISK MANAGEMENT FILE TO REVIEW. THEREFORE, AN EVALUATION OF FAILURE MODES IS NOT REQUIRED. A RISK MANAGEMENT REVIEW WAS PERFORMED FOR THE ACETABULAR CUP. 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. 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 REQUIRED. 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. BASED ON THE INFORMATION PROVIDED WE CANNOT CONFIRM OR FURTHER INVESTIGATE THE REPORTED COMPLAINT, OUR INVESTIGATION REMAINS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONALLY, SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT CANNOT BE PROVIDED DUE TO THE INSUFFICIENT INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H10, ADDITIONAL MANUFACTURER NARRATIVE, ARTICLE REFERENCE: CUSHNIE, D. W., LANTING, B. A., MCCALDEN, R., NAUDIE, D. D., & HOWARD, J. L. (2021). MIDTERM OUTCOMES OF TOTAL HIP ARTHROPLASTY WITH A MODULAR BIRMINGHAM HEAD. HIP INTERNATIONAL, 31(1), 103-108.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON LITERATURE REVIEW "MIDTERM OUTCOMES OF TOTAL HIP ARTHROPLASTY WITH A MODULAR BIRMINGHAM HEAD", FROM 9 PATIENTS THAT INITIALLY HAD EITHER A BHR-THA OR AN R3-THA PROSTHESIS CONSTRUCT IMPLANTED, AN UNSPECIFIED QUANTITY OF THEM WERE REVISED FOR SUSPECTED SOFT TISSUE REACTION AFTER A MEDIAN OF 68 MONTHS POSTOPERATIVELY. OF THESE, 5 HAD SOFT TISSUE ABNORMALITIES NOTED ON ULTRASOUND OR MRI, 3 HAD UNREMARKABLE IMAGING AND ONE WAS REVISED ON CLINICAL GROUNDS WITHOUT MRI. MEAN SERUM CHROMIUM LEVEL WAS 5.7 G/L AND SERUM COBALT WAS 8.1 G/L, WHILE MEAN SERUM TITANIUM WAS 2.0 G/L. ADDITIONAL DETAILS ON THE CLINICAL OUTCOME OF EACH PATIENT ARE UNKNOWN AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE IN REGARDS OF THE IDENTITY OF THE EXPLANTED DEVICES DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267814 UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE| UNKN SYNERGY HIP STEM