BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBODY TAPESTRY BIOINTEGRATIVE IMPLANT WITH INTRODUCER

    MDR report key: 18651093 · Received February 6, 2024

    Report

    Report Number
    3015543569-2024-00001
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    March 31, 2023
    Report Date
    May 19, 2026
    Manufacturer
    EMBODY, INC
    Product Code
    OWY
    UDI-DI
    00810063820107
    PMA / PMN Number
    K220867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G3, G6, H1, H2, H4, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE IS USED FOR TREATMENT. THE REPORTED PATIENT SYMPTOMS ARE CONFIRMED VIA PROVIDED MEDICAL RECORDS, HOWEVER, ALLERGY IS NOT COMFIRMED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DR KNUDSEN NOTE LEFT SHOULDER PAIN, STIFFNESS, CAPSULITIS, AND POSSIBLE INFLAMMATORY REACTION TO BIO INDUCTIVE COLLAGEN SCAFFOLD S/P LEFT SHOULDER ARTHROSCOPIC DEBRIDEMENT, SUBACROMIAL DECOMPRESSION WITH PARTIAL ACROMIOPLASTY, AND PARTIAL ROTATOR CUFF REPAIR WITH PLACEMENT OF AN EMBODY TAPESTRY COLLAGEN SCAFFOLD IMPLANT. POSTOP ARTHROSCOPY: SLING FOR 4-5 DAYS, PT STARTING AT 1 WEEK POSTOP WITH LIMITED PROGRESS AT 3 MONTHS, SEVERE PAIN SINCE WITH DECREASED ROM AND HARD STOP, INTERMITTENT SPASMS, INCREASED WARMTH MRI REPORT IMPRESSION: POSTSURGICAL CHANGES ABOUT THE SUPERIOR ROTATOR CUFF, SUPRASPINATUS TENDINOSIS, MILD GLENOHUMERAL DEGENERATIVE JOINT DISEASE, SUSPECT TEARING OF SUPERIOR LABRUM, NONSPECIFIC INFERIOR GLENOHUMERAL LIGAMENT EDEMA, NARROWED ACROMIOHUMERAL INTERVAL WITH MILD SUBACROMIAL SPURRING. LETTER FROM SIRI & GLIMSTAD.PDF ADDITIONAL SHOULDER CONDITIONS INCLUDING INFLAMMATION, BURSITIS, AND ADHESIVE CAPSULITIS. SYSTEMIC INFLAMMATION AND RHEUMATIC SYMPTOMS QUICKLY RETURNED POSTOP DUE TO ALLERGIC REACTION TO BOVINE DERIVED MATERIAL OF IMPLANT. ADDITIONAL SHOULDER CONDITIONS INCLUDING INFLAMMATION, BURSITIS, AND ADHESIVE CAPSULITIS. SYSTEMIC INFLAMMATION AND RHEUMATIC SYMPTOMS QUICKLY RETURNED POSTOP DUE TO ALLERGIC REACTION TO BOVINE DERIVED MATERIAL OF IMPLANT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT SHOULDER ARTHROSCOPY. THE PATIENT COMPLAINS OF PAIN, STIFFNESS, INFLAMMATION, DECREASED ROM, BURSITIS, AND AN ALLERGIC REACTION TO THE BOVINE-DERIVED MATERIAL OF THE IMPLANT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340260 EMBODY TAPESTRY BIOINTEGRATIVE IMPLANT WITH INTRODUCER MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWY EMBODY, INC 122234 00810063820107

    Patients

    Seq Age Sex Outcome Treatment
    1