BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINDUCTIVE IMPLANT W ARTHRO DEL MED

    MDR report key: 11828620 · Received May 14, 2021

    Report

    Report Number
    3003604053-2021-00194
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    October 8, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    OWY
    UDI-DI
    00885556745021
    PMA / PMN Number
    K140300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. ARTHROSCOPIC IMAGES WERE PROVIDED OF THE SURGICAL SITE AND APPEARED TO SHOW INFLAMED TISSUE. VIDEOS WERE PROVIDED BUT DID NOT HAVE ANY IMAGE OR SOUND. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE INSTRUCTIONS FOR USE WERE 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 CLINICAL EVALUATION WAS PERFORMED BASED ON THE PROVIDED INFORMATION. THE IMPLANT WAS REMOVE AND THE PATIENT DOES NOT HAVE ANY PAIN OR INFLAMMATION TO THE SHOULDER. SINCE NO FURTHER HARM HAS BEEN ALLEGED TO THIS PATIENT, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SOMETHING LIKE A CHEWING GUM WAS FOUND INSTEAD OF THE BIOINDUCTIVE IMPLANT 2 MONTHS AFTER THE FIRST SURGERY. THE PATIENT HAD PAIN AND THE SHOULDER WAS INFLAMED. THE BIOINDUCTIVE IMPLANT WAS REMOVED. PATIENT STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721721 BIOINDUCTIVE IMPLANT W ARTHRO DEL MED MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY SMITH & NEPHEW, INC. UNK 00885556745021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R