BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKN ORTHOPAEDIC RECONSTRUCTION DEV

    MDR report key: 10447727 · Received August 25, 2020

    Report

    Report Number
    1020279-2020-04179
    Event Type
    Death
    Date Received
    August 25, 2020
    Date of Event
    February 4, 2016
    Report Date
    February 26, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, PRODUCT EVALUATION COULD NOT BE PERFORMED AND COMPLAINT COULD NOT BE CONFIRMED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD, RISK MANAGEMENT REVIEW AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. ACCORDING TO CLINICAL/MEDICAL INVESTIGATION ,THE COMPLAINT WAS REPORTED BY THE WIFE OF A PATIENT WHO PASSED AWAY IN 2016 FOR UNKNOWN REASONS. THE PATIENT REPORTEDLY RECEIVED A S&N IMPLANT IN 2014, AND WAS RELEASED FROM THE HOSPITAL WITH AN INFECTION, BUT IT IS UNKNOWN IF/HOW IT WAS TREATED. THE WIFE ADDITIONALLY REPORTED THAT PATIENT HAD ALSO SUFFERED FROM A LOT OF PAIN, WAS NOT ABLE TO WALK, DID NOT HAVE AN APPETITE AND SUFFERED FROM INSTABILITY; ADDITIONALLY, THE COLOR OF THE WHOLE SKIN CHANGED TO BLACK. THE REQUESTED MEDICAL/SURGICAL RECORDS AND CAUSE OF DEATH HAVE NOT BEEN RECEIVED TO DATE. THE REPORTED INFECTION AT DISCHARGE COULD HAVE BEEN A CONTRIBUTING FACTOR; HOWEVER, BASED ON THE LIMITED INFORMATION PROVIDED, THIS COULD NOT BE DEFINITIVELY CONCLUDED. THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED AND/OR ISOLATED TO THE S+N COMPONENTS. SHOULD CLINICALLY RELEVANT DOCUMENTATION/INFORMATION BECOME AVAILABLE TO FULLY EVALUATE THE ROOT CAUSE OF THE REPORTED EVENTS, THE CLINICAL/MEDICAL TASK MAY BE RE-EVALUATED. INFECTION, A POTENTIAL COMPLICATION ASSOCIATED WITH ANY SURGERY, CAN OCCUR AND POSSIBLE CAUSES COULD INCLUDE BUT NOT LIMITED TO CONTAMINATION, PATIENT REACTION, AND POST-OPERATIVE HEALING ISSUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER A PATIENT HAD UNDERGONE BILATERAL REVISION SURGERIES FOR RECALLED DEVICES FROM AN UNKNOWN COMPANY, THE PATIENT RECEIVED BIOMET IMPLANTS IN 2012 ON THE LEFT HIP AND S+N IMPLANTS IN 2014 ON THE RIGHT HIP. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH AN INFECTION, BUT IT IS UNKNOWN IF/HOW IT WAS TREATED. THE PATIENT HAD ALSO SUFFERED FROM A LOT OF PAIN, WAS NOT ABLE TO WALK, DID NOT HAVE AN APPETITE AND SUFFERED FROM INSTABILITY; ADDITIONALLY, THE COLOR OF THE WHOLE SKIN CHANGED TO BLACK. THE PATIENT PASSED AWAY IN 2016 FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915549 UNKN ORTHOPAEDIC RECONSTRUCTION DEV PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death