BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ANTHOLOGY HIP IMPL

    MDR report key: 10103812 · Received May 30, 2020

    Report

    Report Number
    1020279-2020-01923
    Event Type
    Injury
    Date Received
    May 30, 2020
    Date of Event
    May 18, 2020
    Report Date
    October 13, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 C.F.R. PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW 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, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL EVALUATION CONCLUDED THAT, 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 (AE#1) 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 AE(#1). 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. NO FURTHER MEDICAL ASSESSMENT COULD BE RENDERED AT THIS TIME. SHOULD CLINICALLY RELEVANT DOCUMENTATION/INFORMATION BECOME AVAILABLE, THE CLINICAL/MEDICAL TASK MAY BE RE-EVALUATED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE DAMAGED PRODUCT, IMPLANT CORROSION, OR METAL-ON-METAL CONTACT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED OR PRODUCT INFORMATION, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. ADDITIONAL INFORMATION: D3 AND G1.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. IT WAS INITIALLY BELIEVED THAT THE ANTHOLOGY STEM HAD BEEN EXPLANTED. NONETHELESS, ON (B)(6) 2020, THE MANUFACTURER BECAME AWARE OF NEW INFORMATION THAT INDICATED STEM RETENTION. THE RE-ASSESSMENT DETERMINED THAT THE ISSUE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. THIS REPORT WAS SUBMITTED BASED ON INFORMATION THAT SMITH & NEPHEW HAD NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. 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).

    Description of Event or Problem · 0

    STUDY: ANTHOLOGY R11006-1; SUBJECT ID: WHH004; 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.

    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 THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    [STUDY: ANTHOLOGY R11006-1; SUBJECT ID: WHH004; 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
    567496 UNKN ANTHOLOGY HIP IMPL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R