BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS ANCHOR PLUG 12MM

    MDR report key: 19491880 · Received June 7, 2024

    Report

    Report Number
    0001825034-2024-01508
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 17, 2024
    Report Date
    November 25, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304259713
    PMA / PMN Number
    K031804
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: JAPAN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS(REPORTED) . (B)(4) CPS SM SPDL WITH PINS 600LBF LOT# 981260.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. INSUFFICIENT INFORMATION TO PERFORM COMPATIBILITY CHECK. X-RAY REVIEW BY THIRD PARTY HCP STATES THAT THERE IS INTERVAL PROGRESSIVE DECREASE IN THE OSS IMPLANT ANCHOR PLUG-SPINDLE DISTANCE AND PROGRESSIVE BACKING OUT OF A DISTAL FEMORAL SCREW WITH INCREASING PERIOSTEAL NEW BONE FORMATION ALONG THE DISTAL FEMUR AS NOTED. COMPLAINT IS CONFIRMED VIA X-RAY EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT FELT A PAIN AROUND ONE MONTH POST REVISION. VISITED THE HCP FOR EXAMINATION EARLY MAY AND THE X-RAYS SHOWED SHORTENING BETWEEN THE ANCHOR PLUG AND SPINDLE AS IN THE PREVIOUS VISIT. NO REVISION HAS TAKEN PLACE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265533 CPS ANCHOR PLUG 12MM PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 497110 00880304259713

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Other SEE H11 NARRATIVE.