BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM MOD ARTHRO 0 DEG LCK COLLAR

    MDR report key: 19518876 · Received June 12, 2024

    Report

    Report Number
    0001825034-2024-01558
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 16, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00880304082977
    PMA / PMN Number
    K042409
    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. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. VISUAL EVALUATION OF A PICTURE PROVIDED IDENTIFIED AN EXPLANTED COLLAR WITH FOREIGN MATERIAL ON IT. RADIOGRAPHIC REVIEW DID NOT IDENTIFY ANY HARDWARE FAILURE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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). D10 MEDICAL DEVICES: CPS LG SPDL WITH PINS 600LBF, CATALOG #: 178357, LOT #: 030780. OSS POR STRAIGHT STEM 14.5X150, CATALOG #: 150450, LOT #: 463180. MOD ARTHRO NL 3CM DIASL CNCTR, CATALOG #: CP260607, LOT #: 643710. MOD ARTHRO NL 3CM ELIP CNCTR, CATALOG #: CP260608, LOT #: 360440. CPS NUT CO-CR-MO ALLOY, CATALOG #: 178512, LOT #: 954300. CPS TRANSVERSE PIN 6PK 36MM, CATALOG #: 178528, LOT #: 097450. CPS ANCHOR PLUG 20MM, CATALOG #: 178410, LOT #: 752800. G2 FOREIGN SOURCE: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390550 ORTHOPEDIC SALVAGE SYSTEM MOD ARTHRO 0 DEG LCK COLLAR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 893750 00880304082977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R