BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETLR CUP HAP 52MM W/ IMPTR

    MDR report key: 10105529 · Received June 1, 2020

    Report

    Report Number
    3005975929-2020-00169
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    July 8, 2016
    Report Date
    July 20, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502575
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PART ADDED AS CONCOMITANT.

    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 HIP REVISION SURGERY WAS PERFORMED. AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT, AND ADDITIONAL INFORMATION HAVE BEEN REQUESTED FOR THIS COMPLAINT BUT HAVE NOT BECOME AVAILABLE. NO DEVICE PART AND BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW AND DEVICE LABELLING / IFU REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. A RISK MANAGEMENT REVIEW WAS PERFORMED. NO ADDITIONAL RISKS WERE IDENTIFIED AS RESULT OF THE REPORTED EVENT AND NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. 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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. THE EXPLANTED DEVICES WERE A 52MM BHR CUP AND A 46MM BHR HEAD. THE METAL ION LEVELS WERE CHROMIUM IN URINE : 2.10 HG/G CREAT. COBALT IN URINE: 5 HG/G CREAT. METAL ON WHOLE BLOOD: NOT DETECTED. THE PATIENT OUTCOME IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. THE EXPLANTED DEVICES WERE A 52MM BHR CUP AND A 46MM BHR HEAD. THE METAL ION LEVELS WERE CHROMIUM IN URINE: 2.10 H UG/G CREAT. COBALT IN URINE: 5 H UG/G CREAT. METAL ON WHOLE BLOOD: NOT DETECTED. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569244 ACETLR CUP HAP 52MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN 03596010502575

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKN BHR MODULAR HEAD SLEEVE