BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS DEVICE CPS SM SPDL WITH PINS 600LBF

    MDR report key: 20351604 · Received October 2, 2024

    Report

    Report Number
    0001825034-2024-02312
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 30, 2024
    Report Date
    February 6, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304509078
    PMA / PMN Number
    K183553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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; B5; D2; G1; G3; G6; H1; H2; H3; H6. THE EVENT CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: OSS TIBIAL POLY BEARING 14MM: CATALOG#150411, LOT#65739979; OSS POLY TIBIAL BUSHING: CATALOG#150476, LOT#65733841; OSS REINFORCED YOKE: CATALOG#150493, LOT#65964072; OSS POLY BUMPER LOCK PIN: CATALOG#150510, LOT#65725246; OSS 4CM TAPERED DIAPH SEGMENT: CATALOG#151837, LOT#482670; OSS 4CM TAPERED DIAPH SEGMENT: CATALOG#151837, LOT#66097444; OSS RS 7 CM MOD SEG FMRL-RT: CATALOG#161011, LOT#66163582; OSS RS POLY FEM BUSHINGS SET/2: CATALOG#161034, LOT#65791052; OSS RS POLY FEM BUSHINGS SET/2: CATALOG#161034, LOT#66198016; OSS RS AXLE: CATALOG#161035, LOT#66021154; CPS ANCHOR PLUG 10MM: CATALOG#178400, LOT#497100; CPS ANCHOR PLUG 12MM: CATALOG#178402, LOT#497110; CPS NUT CO-CR-MO ALLOY: CATALOG#178512, LOT#65766783; CPS TRANSVERSE PIN 6PK 32MM: CATALOG#178527, LOT#173340; CPS CENTERING SLEEVE 15MM: CATALOG#178537, LOT#65753493; CPS/OSS 5CM TPR ADAPT W/OSS SC: CATALOG#178711, LOT#65850160. G2: FOREIGN: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, 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 A PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, EIGHT (8) MONTHS POST-IMPLANTATION, MIGRATION WAS SEEN IN THE COMPRESS SPINDLE AND THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE AFFECTED COMPONENT. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007303 COMPRESS DEVICE CPS SM SPDL WITH PINS 600LBF PROTHESIS, KNEE MBF ZIMMER BIOMET, INC. 981260 00880304509078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE