BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 26MM RNGLC LNR+3HW SZ20 SET

    MDR report key: 19116558 · Received April 16, 2024

    Report

    Report Number
    0001825034-2024-00243
    Event Type
    Injury
    Date Received
    April 16, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 13-104042; LOT# UNKNOWN. ITEM# 163623; LOT# UNKNOWN. ITEM# CP162113; LOT# UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. 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 THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE APPROXIMATELY THIRTEEN (13) YEARS AGO AND IS NOW BEING CONSIDERED FOR A PMI DEVICE DUE TO A WORN POLY LINER AND PRE-EXISTING PATIENT COMORBIDITIES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582296 E1 26MM RNGLC LNR+3HW SZ20 SET PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED JWH ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE NARRATIVE IN H10