BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT FEMORAL CR

    MDR report key: 17208347 · Received June 27, 2023

    Report

    Report Number
    0001825034-2023-01426
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 7, 2023
    Report Date
    October 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: SUGGESTED COMPONENT CODE: MECHANICAL 04 - FEMUR. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED. RADIOGRAPHS WERE REVIEWED BY A HEALTHCARE PROFESSIONAL, WHICH IDENTIFIED IMPLANT FIT AND ALIGNMENT WERE MAINTAINED. BONE QUALITY APPEARED OSTEOPENIC. REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS PRODUCT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01425. D10 MEDICAL DEVICES: VNGD CR TIB BRG 10X71/75 CATALOG#: 183440 LOT#: 901560. POLISHED FINNED TIB TRAY 71MM CATALOG#: 141253 LOT#: 2018100120. G2 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED DUE TO PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    1647070 UNKNOWN RIGHT FEMORAL CR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.