BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPESTRY 40X30MM

    MDR report key: 21696860 · Received March 26, 2025

    Report

    Report Number
    3015543569-2025-00002
    Event Type
    Injury
    Date Received
    March 26, 2025
    Report Date
    September 10, 2025
    Manufacturer
    EMBODY, INC
    Product Code
    OWY
    UDI-DI
    00810063820053
    PMA / PMN Number
    K201572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, A3, A4, B4, B5, B7, D6A, G2, G3, G6, H1, H2, H6, H11 CORRECTED SECTIONS: D1, D2,D4, E1, E2, E3 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, D4, G3, G6, H2, H3, H4, H6, H11 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. CRF WAS REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE CRF IDENTIFIED THE FOLLOWING: RIGHT HIP PAIN, TROCHANTERIC BURSITIS WITH TREATMENT OF STEROID INJECTION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE REPORTED EVENT IS UNCONFIRMED. 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

    (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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT HIP PAIN, TROCHANTERIC BURSITIS, AND RECEIVED A STEROID INJECTION POST INITIAL IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN UNKNOWN PROCEDURE AND EXPERIENCED RIGHT HIP PAIN, TROCHANTERIC BURSITIS, AND RECEIVED A STEROID INJECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131454 TAPESTRY 40X30MM MESH, SURGICAL OWY EMBODY, INC T-250 00810063820053

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other