BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINDUCTIVE IMPLANT W/ARTH DEL LRG

    MDR report key: 11823502 · Received May 13, 2021

    Report

    Report Number
    3003604053-2021-00188
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    September 10, 2020
    Report Date
    February 25, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OWY
    UDI-DI
    00885556735664
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). CORRECTED INFORMATION IN D1, D2, D4 (CATALOG & UDI), AND G4 (510K).

    Additional Manufacturer Narrative · 0

    H10: H2: ADDITIONAL INFORMATION: H6: HEALTH EFFECT - IMPACT CODE. H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. BASED ON THE LIMITED INFORMATION PROVIDED A THOROUGH MEDICAL ASSESSMENT COULD NOT BE PERFORMED; THEREFORE, WE ARE UNABLE TO CONCLUDE SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, APPROX.. 6 MONTHS POST-OPERATION, THE PATIENT RETURNED TO THE CLINIC REPORTING PAIN AND INFLAMMATION. THE PATIENT SAID A MATTRESS HOT HIS SHOULDER. THE MRIS SHOWED INFLAMMATION AND THE PRESENCE OF RICE BODIES AROUND THE REPAIR SITE. A RECENT MRI LOOKED GOOD AND NORMAL, RICE BODIES AND INFLAMMATION WERE GONE. PATIENT HAD AN INFECTION AND RECOVERED FOLLOWING ANTIBIOTICS. NO FOLLOW-UP SURGERY/WASHOUT WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712445 BIOINDUCTIVE IMPLANT W/ARTH DEL LRG MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY SMITH & NEPHEW, INC. 4566 A7954 00885556735664
    712449 BIOINDUCTIVE IMPLANT W/ARTH DEL LRG MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY SMITH & NEPHEW, INC. 4566 A7954 00885556735664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male