BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM EXTENSION STRAIGHT LONG 15MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM)

    MDR report key: 12017281 · Received June 17, 2021

    Report

    Report Number
    0001822565-2021-01664
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 21, 2021
    Report Date
    September 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: B4, B5, D4, G4, H1, H2, H3, H4, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: ROTATING HINGE KNEE FEMORAL 00588001502 LOT 61314950 KRO PROSTHESIS, KNEE; NEXGEN FEMORAL AUGMENT 00599003521 LOT 60880980; NEXGEN FEMORAL AUGMENT 00599003524 LOT 61737801; PALACOS R+G CEMENT 66022663 LOT 72474274; ARTICULAR SURFACE 00588005023 LOT 61718734; UNKNOWN TIBIAL COMPONENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2021-01665, 0001822565-2021-01666, 0001822565-2021-01667, 0001822565-2021-01668.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION KNEE ARTHROPLASTY TEN YEARS POST IMPLANTATION DUE TO LOOSENING OF THE FEMORAL COMPONENTS AFTER A FALL. THE CAUSE OF THE FALL IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917403 STEM EXTENSION STRAIGHT LONG 15MM DIA X 155MM LENGTH(COMBINED LENGTH 200MM) PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 61214730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R