BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    MDR report key: 17097935 · Received June 9, 2023

    Report

    Report Number
    0002648920-2023-00107
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    March 10, 2022
    Report Date
    March 3, 2026
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    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 # 00598605701 LOT # 63656335. MANUFACTURE DATE: MAY 5, 2017. STERILE EXPIRY DATE: APR 30, 2027. UDI: (B)(4). 510K: K173057, PRO CODE: JWH. OR ITEM # 00598605701 LOT # 63656335. MANUFACTURE DATE: MAY 5, 2017. STERILE EXPIRY DATE: APR 30, 2027. UDI: (B)(4). 510K: K173057, PRO CODE: JWH. D10 - MEDICAL PRODUCT: FEMORAL COMPONENT ITEM # 00596401751 LOT # 63691139. STEMMED NONAUGMENTABLE TIBIAL COMPONENT ITEM # 00598605701 LOT # 63656335. ARTICULAR SURFACE ITEM # 00596405010 LOT # 63045609. ALL POLY PETELLA ITEM # 00597206538 LOT # 63615078. HEADED SCREW 48 MM LENGTH ITEM # 00579104100 LOT # 63615261 QTY 2. 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, 0001822565-2022-01951, 0002648920-2023-00108 AND 0001822565-2023-01525. H3 OTHER TEXT : REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 PATIENT IS EXPERIENCING UNKNOWN ISSUE POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228385 STEMMED NONAUGMENTABLE TIBIAL COMPONENT PROSTHESIS KNEE JWH ZIMMER MANUFACTURING B.V. N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| O| R SEE H10 NARRATIVE.