BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM ID US COCR LNR 62MM

    MDR report key: 8073987 · Received November 15, 2018

    Report

    Report Number
    3005975929-2018-00457
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    March 21, 2017
    Report Date
    November 19, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR, 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. - ATTACHMENT: [220373 SUMMARY.PDF]

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT LEFT HIP REVISION SURGERY WAS PERFORMED. DURING THE REVISION, THE R3 LINER, HEMI HEAD AND MODULAR SLEEVE WERE REMOVED. THE R3 SHELL AND ANTHOLOGY STEM 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. REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY WAIVERS, CONCESSIONS, MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. THE ORIGIN OF THE REPORTED INFECTION OF THE HIP JOINT IS HIGHLY LIKELY OF AN EXOGENOUS NATURE AND THERE IS NO EVIDENCE THAT OUR PRODUCT CONTRIBUTED TO THE INFECTION. THE INTRAOPERATIVE FINDINGS OF DISCOLORED TISSUE, CORROSION AND PSEUDOTUMOR ARE FINDINGS THAT COULD BE ASSOCIATED WITH METALLOSIS BUT THE SURGEON REPORTED THAT THE FINDINGS WERE NOT UNUSUAL AND DIDN¿T IDENTIFY METALLOSIS AS A ROOT CAUSE. WITHOUT THE SUPPORTING LAB/PATHOLOGY RESULTS, IMAGING, AND/OR THE ANALYSIS OF THE EXPLANTED COMPONENTS, THE ROOT CAUSE CANNOT BE CONFIRMED, AND IT CANNOT BE CONCLUDED THAT THE REPORTED REACTIONS 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 INFORMATION: EVENT,BRAND NAME, OTHER #, CONCOMITANT MEDICAL PRODUCTS AND DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY OF THE LEFT HIP WAS PERFORMED DUE TO LEFT PELVIS ABSCESS COLLECTION AROUND THE ILIOPSOAS REGION AND ALSO COMMUNICATING WITH THE HIP JOINT WITH AN ACUTE INFECTION. FEMORAL HEAD AND LINER WERE REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY OF THE LEFT HIP WAS PERFORMED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915526 50MM ID US COCR LNR 62MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08MW20876

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71335562/ R3 3 HOLE ACET SHELL 62MM/ 08JM02036| 71356107/ ANTHOLOGY POROUS SZ 7/ 09BM04322| 74122550/ HEMI HEAD 50MM/ 08KW19535| 74222100/ MOD SLEEVE -4MM 12/14/ 08EW16954| UNKNOWN BHR DEVICE/UNKNOWN LOT| UNKNOWN BHR DEVICE/UNKNOWN LOT