BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESURFACING FEMORAL HEAD 50MM

    MDR report key: 7304015 · Received February 28, 2018

    Report

    Report Number
    1020279-2018-00254
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    January 1, 2013
    Report Date
    November 6, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDI
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE BHR HEAD WAS REMOVED. THE BHR CUP REMAINED IMPLANTED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. APPROXIMATELY 14 MONTHS POST IMPLANTATION, DUE TO ONSET OF SEVERE PAIN, THE PATIENT UNDERWENT A REVISION/CONVERSION OF THE FEMORAL COMPONENT TO A THA; THE CUP REMAINED IMPLANTED. THE REVISION OPERATIVE REPORT NOTED SOME SUBSIDENCE AND LOOSENING OF THE FEMORAL COMPONENT, WHICH WAS EASILY REMOVED. IT CANNOT BE CONCLUDED THAT THE REPORTED REACTIONS/EVENTS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, AND OUR INVESTIGATION REMAINS INCONCLUSIVE. 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.

    Additional Manufacturer Narrative · 1

    THE 510K HAS BEEN SELECTED ALTHOUGH WE HAVE YET TO RECEIVE ANY INFORMATION ABOUT THE ADDITIONAL DEVICES USED IN THIS PATIENT'S SURGERY. THIS PRODUCT LINE IS ALSO ASSOCIATED WITH PMA P030022, PRODUCT CODE MRA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PAIN. DURING REVISION BHR HEAD WAS REMOVED, HOWEVER BHR CUP REMAINED IMPLANTED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. SINCE DEVICE PART DETAILS WERE RECEIVED FOR INVESTIGATION, MANUFACTURING RECORD REVIEW AND ASSESSMENT OF THE REPORTED EVENT CAN BE PERFORMED. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. ACCORDING TO THE PROVIDED REVISION REPORT, THE PATIENT HAD SEVERE PAIN OVER THE LAST 2 TO 3 MONTHS, SOME SUBSIDENCE OF THE FEMORAL COMPONENT. DURING THE REVISION THE FEMORAL COMPONENT WAS FOUND GROSSLY LOOSE. BASED ON THE PROVIDED INFORMATION THE REASON FOR THE REVISION WAS ASEPTIC LOOSENING. REVIEW OF THE PROVIDED REVISION REPORT DID NOT PROVIDE INSIGHT INTO THE REASON FOR THE LOOSENING. 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 PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION SURGERY DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146948 RESURFACING FEMORAL HEAD 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI SMITH & NEPHEW, INC. 10DW26822

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 74122158/ ACETABULAR CUP SIZE 52/58/ 10EW27785