BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEADED SCREW

    MDR report key: 17088637 · Received June 8, 2023

    Report

    Report Number
    0001822565-2023-01525
    Event Type
    Injury
    Date Received
    June 8, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, HEADED SCREW WILL BE VOIDED AS IT WAS INSTRUMENT NOT AN IMPLANT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D4: TWO (2) DEVICE IDS WERE PROVIDED BY THE CUSTOMER/REPORTER; OF THESE, ONLY ONE (1) WAS REPORTED FOR UNKNOWN ISSUE. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 00579104100, LOT#: 63615261. MANUFACTURE DATE: MAR 3, 2017. STERILE EXPIRY DATE: FEB 28, 2027. UDI: (B)(4). 510K: EXEMPT, PRO CODE: LXH. OR ITEM#: 00579104100, LOT#: 63615261. MANUFACTURE DATE: MAR 3, 2017. STERILE EXPIRY DATE: FEB 28, 2027. UDI: (B)(4). 510K: EXEMPT, PRO CODE: LXH. D10: MEDICAL PRODUCT: FEMORAL COMPONENT ITEM#: 00596401751, LOT#: 63691139. STEMMED NONAUGMENTABLE TIBIAL COMPONENT ITEM#: 00598605701, LOT#: 63656335 QTY 2. ARTICULAR SURFACE ITEM#: 00596405010, LOT#: 63045609. ALL POLY PETELLA ITEM#: 00597206538, LOT#: 63615078. HEADED SCREW 48 MM LENGTH ITEM#: 00579104100, LOT#: 63615261. PALACOS R+G ITEM#: 66017569, LOT#: 86394614, QTY 2. G2: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 3007963827-2023-00149, 0002648920-2023-00107, 0001822565-2022-01951, 0002648920-2023-00108.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, HEADED SCREW WILL BE VOIDED AS IT WAS INSTRUMENT NOT AN IMPLANT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT IS EXPERIENCING UNKNOWN ISSUE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274161 HEADED SCREW PROSTHESIS KNEE LXH ZIMMER BIOMET, INC. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE.