BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD ARTHRO 0 DEG LCK COLLAR

    MDR report key: 12712076 · Received October 28, 2021

    Report

    Report Number
    0001825034-2021-02979
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    October 6, 2021
    Report Date
    February 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00880304082977
    PMA / PMN Number
    K042409
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, AND H10 THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. A PHOTOGRAPH OF THE LOCKING COLLAR WAS PROVIDED HOWEVER A FRACTURED LOCKING SCREW CANNOT BE IDENTIFIED. 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. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS CMNTD PROX TIB STEM 15X150, ITEM# 150447, LOT# 403160. MOD ARTHRO NL 3CM ELIP CNCTR, ITEM# CP260608, LOT# 029880. MOD ARTHRO 0 DEG LCK COLLAR, ITEM# CP260600, LOT# 280030. MOD ARTHRO NL 3CM ELIP CNCTR, ITEM# CP260608, LOT# 119640. OSS CMNTD PROX TIB STEM 11X15, ITEM# 150445, LOT# 723840. OSS CMNTD PROX TIB STEM 13X150, ITEM# 150446, LOT# 133100. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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 · 1

    IT WAS REPORTED THAT A SCREW FRACTURED OFF IN A COLLAR WITH TORQUE WRENCH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609409 MOD ARTHRO 0 DEG LCK COLLAR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 280030 00880304082977

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female