BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F

    MDR report key: 12857312 · Received November 22, 2021

    Report

    Report Number
    3007963827-2021-00301
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    November 8, 2021
    Report Date
    February 22, 2022
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K960279
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF IMPLANTATION. BONE CEMENT ADHERES TO THE POSTERIOR SIDE OF THE FEMUR. NO BONE CEMENT WAS SEEN ON THE TIBIAL PLATE. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-453-22 LOOSENING IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0002648920-2021-00413. INITIAL 2014. MEDICAL PRODUCT STEMMED TIBIAL COMPONENT PRECOAT SIZE 5 ITEM# 00598004701 LOT# 62503831. ARTICULAR SURFACE SIZE EF 12 MM HEIGHT ITEM# 00596404012 LOT# 62382048. REPORT SOURCE - (B)(6). CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO LOOSENING. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755127 FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62382048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10.