BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGHT SIZE E CEMENTED OPTION FEMORAL COMPONENT FEMORAL

    MDR report key: 17491590 · Received August 9, 2023

    Report

    Report Number
    0001822565-2023-02112
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 17, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024224810
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.   H6-COMPONENT CODE- SUGGESTED CODE: MECHANICAL (G4)- FEMUR. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED A BROKEN FEMORAL COMPONENT. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS/THESE ITEM(S) AND THE REPORTED PART AND LOT COMBINATION(S). MEDICAL RECORDS WERE NOT PROVIDED. THIS COMPLAINT HAS BEEN CONFIRMED BY THE PICTURE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE FACILITY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: 00-5990-035-23 NEXGEN AUGMENT BLOCK DISTAL, SIZE E, 15MM LOT# 63446102; 00-5990-035-20 NEXGEN DISTAL PRECOAT AGMT BLOCK, SIZE E, 10MM LOT# 63419328; 00-5964-032-20 NEXGEN LPS-FLEX FIXED NSM ART SURF EF 3-4, 20MM LOT# 63794048; 00-5988-021-12 NEXGEN OFFSET STEM EXT 12MM DIA X 200MM,(155MM) LOT# 63620558.

    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 THE FEMORAL IMPLANT FRACTURED WHERE THE SET SCREW LOCKS INTO THE STEM. THE FEMORAL IMPLANT WAS REVISED. THE ARTICULAR SURFACE, STEM AND AUGMENTS WERE REVISED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014121 RIGHT SIZE E CEMENTED OPTION FEMORAL COMPONENT FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64794372 00889024224810

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R