BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRMINGHAM HIP MODULAR HEAD (BHMH)

    MDR report key: 10103810 · Received May 30, 2020

    Report

    Report Number
    1020279-2020-01922
    Event Type
    Injury
    Date Received
    May 30, 2020
    Date of Event
    May 18, 2015
    Report Date
    November 10, 2021
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    KWL
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2021 WE RECEIVED ADDITIONAL INFORMATION FROM THE HEALTHCARE/INVESTIGATION SITE THAT HAS TRIGGERED THIS SUPPLEMENTAL REPORT. PLEASE BE AWARE THAT THE CORRECT MANUFACTURER NUMBER FOR THE EXPLANTED BHR MODULAR HEAD IS 3005975929, AND NOT 1020279. THE MANUFACTURER HAS ALREADY REPORTED TO THE FDA THE EXPLANTATION OF THE ACETABULAR SHELL (1020279-2020-01920), THE ACETABULAR LINER (1020279-2020-01921), AND THE MODULAR HEAD/SLEEVE (1020279-2020-01922).

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A RIGHT HIP REVISION SURGERY WAS PERFORMED; THE ACETABULAR COMPONENT WAS EXPLANTED, THE STEM REMAINED IMPLANTED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. SINCE PART DETAILS WERE NOT RECEIVED FOR INVESTIGATION NO THOROUGH MANUFACTURING RECORD REVIEW AND ASSESSMENT OF THE REPORTED EVENT CAN BE PERFORMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. PER COMPLAINT DETAILS, THE PATIENT REQUIRED A SECOND REVISION DUE TO ELEVATED METAL IONS WHICH INCLUDED CONVERSION OF THE RIGHT BHR-THA CONSTRUCT TO A FULL RIGHT THA/REMOVAL OF THE ACETABULAR COMPONENT APPROXIMATELY 6 YEARS POST 1ST REVISION. REPORTEDLY, THE ANTHOLOGY STEM SIZE 5 REMAINED IN-SITU; HOWEVER, THE SITE WAS ¿UNABLE TO PROVIDE DATA SO FAR¿ REGARDING THE ACETABULAR COMPONENT. WITHOUT THE REQUESTED MEDICAL DOCUMENTATION, THE CLINICAL ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE FULLY ASSESSED OR CONCLUDED. THE PATIENT IMPACT BEYOND THE REPORTED ELEVATED METAL IONS AND SUBSEQUENT REVISION COULD NOT BE DETERMINED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED OR PRODUCT INFORMATION, OUR INVESTIGATION COULD NOT PROCEED AND REMAINS INCONCLUSIVE. DUE TO THE INSUFFICIENT INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, AND WE ARE UNABLE TO DETERMINE SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. SINCE PART DETAILS WERE NOT RECEIVED FOR INVESTIGATION NO THOROUGH MANUFACTURING RECORD REVIEW AND ASSESSMENT OF THE REPORTED EVENT CAN BE PERFORMED. SMITH AND NEPHEW HAS NOT RECEIVED THE DEVICE / ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. WITHOUT ADDITIONAL INFORMATION ABOUT THIS PATIENT¿S PARTICULAR CASE, OUR INVESTIGATION REMAINS INCONCLUSIVE. NO PREVENTIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    [STUDY: ANTHOLOGY R11006-1; SUBJECT ID: WHH004; AE#: 1] IT WAS REPORTED THAT, AFTER A R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE RIGHT HIP, THE CLINICAL SUBJECT EXPERIENCED ELEVATED METAL IONS. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY TO REMOVE THE ACETABULAR COMPONENT, RENDERING A FULL CONVERSION TO THA. THE ANTHOLOGY SIZE 5 STEM WAS LEFT IN-SITU. THIS COMPLAINT IS AGAINST THE MODULAR HEAD / SLEEVE. THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A RIGHT THA SURGERY HAD BEEN PERFORMED, THE CLINICAL SUBJECT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS RESOLVED BY PERFORMING A REVISION SURGERY. AN UNSPECIFIED ANTHOLOGY SIZE 5 STEM, AN UNSPECIFIED SIZE 46 METAL FEMORAL HEAD, AN UNSPECIFIED SIZE 46/54 CHROME LINER AND AN UNSPECIFIED MIDLAND MEDICAL UNCEMENTED SIZE 54 ACETABULAR SHELL WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    [STUDY: (B)(6); SUBJECT ID: (B)(6); AE#: UNK] IT WAS REPORTED THAT, AFTER A RIGHT THA SURGERY HAD BEEN PERFORMED, THE CLINICAL SUBJECT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT THAT WAS RESOLVED BY PERFORMING A REVISION SURGERY. AN UNSPECIFIED ANTHOLOGY SIZE 5 STEM, AN UNSPECIFIED SIZE 46 METAL FEMORAL HEAD, AN UNSPECIFIED SIZE 46/54 CHROME LINER AND AN UNSPECIFIED MIDLAND MEDICAL UNCEMENTED SIZE 54 ACETABULAR SHELL WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567494 BIRMINGHAM HIP MODULAR HEAD (BHMH) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN
    567512 BIRMINGHAM HIP MODULAR HEAD (BHMH) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN
    567514 BIRMINGHAM HIP MODULAR HEAD (BHMH) PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE.