BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SMITH+NEPHEW DEV

    MDR report key: 11837142 · Received May 17, 2021

    Report

    Report Number
    3003604053-2021-00199
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    February 27, 2020
    Report Date
    June 26, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD, COMPLAINT HISTORY, INSTRUCTIONS FOR USE, OR RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. ATTEMPTS TO OBTAIN MEDICAL DOCUMENTS WERE UNSUCCESSFUL AND THUS A THOROUGH MEDICAL INVESTIGATION WAS NOT PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. 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 CASE-(B)(4). LITERATURE: THE INTERPOSITION OF SOFT TISSUE BETWEEN THE CORTICAL BUTTON AND FEMORAL LATERAL CORTEX SIGNIFICANTLY INCREASES BUTTON MIGRATION BUT DOES NOT NEGATIVELY AFFECT KNEE STABILITY AND CLINICAL OUTCOME. DOI.ORG/10.1016/J.KNEE.2020.02.021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW " THE INTERPOSITION OF SOFT TISSUE BETWEEN THE CORTICAL BUTTON AND FEMORAL LATERAL CORTEX SIGNIFICANTLY INCREASES BUTTON MIGRATION BUT DOES NOT NEGATIVELY AFFECT KNEE STABILITY AND CLINICAL OUTCOME", AFTER AN ACL RECONSTRUCTION USING A STAPLE, A PATIENT HAD A SUPERFICIAL WOUND INFECTION. THE COMPLICATION WAS TREATED WITH DEBRIDEMENT AND ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732377 UNKN SMITH+NEPHEW DEV DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R