BEUDAMED
    FDA Adverse Event Death Summary report: N

    R3 PRIMARY CONST 66-70MM LINERS XL

    MDR report key: 3968399 · Received July 30, 2014

    Report

    Report Number
    1020279-2014-00469
    Event Type
    Death
    Date Received
    July 30, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. OUR INVESTIGATION INCLUDED A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE WHICH DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF THE DEVICE RISK MANAGEMENT PLAN AS WELL AS THE ASSOCIATED MANUFACTURING AND LABELING SPECIFICATIONS DID NOT REVEAL ANY ISSUES THAT WOULD POTENTIALLY LEAD TO THIS OUTCOME. THIS ISSUE WAS REVIEWED BY OUR CLINICAL INVESTIGATION TEAM WHO CONCLUDED A REVIEW OF THE AVAILABLE CLINICAL EVIDENCE DOES NOT REVEAL A DIRECT LINK BETWEEN OUR DEVICE AND THE REPORTED EVENT/PATIENT OUTCOME. THE DEVICE WAS EVALUATED BY OUR RESEARCH TEAM. IT WAS CONCLUDED THAT THE R3 CONSTRAINED LINER WAS DEFORMED ALONG THE RIM OF THE LINER. THE DEFORMATION ALONG THE RIM CAN POTENTIALLY BE ATTRIBUTED TO IMPINGEMENT OF THE NECK OF THE FEMORAL STEM. THIS MAY HAVE LED TO DISASSOCIATION OF THE HEAD AND/OR LINER. THE FEMORAL HEAD AND SHELL WERE NOT AVAILABLE FOR INVESTIGATION. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW HAS BECOME AWARE THAT THE PATIENT HAS DIED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445037 R3 PRIMARY CONST 66-70MM LINERS XL HIP IMPLANT JDH SMITH & NEPHEW, INC. 10DM14894R

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 71338742 - 11AM11216