BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMPLANT

    MDR report key: 8864335 · Received August 6, 2019

    Report

    Report Number
    1020279-2019-02926
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    November 28, 2017
    Report Date
    September 27, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED. THE MEDICAL INVESTIGATION CONCLUDED THAT ALL DOCUMENTS AND IMAGES PROVIDED AS OF THIS DATE HAVE BEEN REVIEWED AND CONSIDER AND UNLESS NOTED DO NOT CONTRIBUTE TO THE CLINICAL INVESTIGATION. THE IMPACT TO THIS PATIENT HAS BEEN MULTIPLE INTERVENTIONS AND SURGERIES WITH DEBILITY AND RECOVERY PAIN. THE CLINICAL INFORMATION PROVIDED, OF THE ¿OSTEOLYTIC/METALLOSIS AND SYNOVIAL REACTION¿ MAY BE CONSISTENT WITH A REACTION TO METAL DEBRIS. HOWEVER, THE SOURCE AND THE ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE DOCUMENTATION. THE ROOT CAUSE OF THE DISLOCATIONS CANNOT BE CONCLUDED BASED ON THE INFORMATION PROVIDED. WITHOUT THE ACTUAL PRODUCT INVOLVED AND/OR DEVICE INFORMATION, OUR INVESTIGATION CANNOT PROCEED. IF THE DEVICES OR NEW INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINTS CAN BE RE-OPENED. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. SMITH AND NEPHEW IMPLANTS 62 SHELL, 40 LINER, 40 CERAMIC OXINIUM HEAD AND SIZE 4 HIGH OFFSET SMF STEM WERE REMOVED AND REPLACED WITH DEPUY PINNACLE 64MM ACETABULAR CUP, 6.5MMX45MM CANCELLOUS BONE SCREWS, PINNACLE ALTRX POLYETHYLENE ACETABULAR LINER +4 LATERALIZED 10- DEGREE ANGLED, DEPUY CORAIL REVISION FEMORAL STEM, SIZE 15/HIGH OFFSET, BIOLOX DELTA CERAMIC FEMORAL HEAD +12X36MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658138 HIP IMPLANT PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R