BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS TRANSVERSE PIN 6PK 28MM

    MDR report key: 23010307 · Received September 9, 2025

    Report

    Report Number
    0001825034-2025-02852
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 19, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304260511
    PMA / PMN Number
    K043547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. UPON REASSESSMENT OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT SHOULD BE VOIDED. 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). D6: IMPLANT DATE - 2022 D10: CONCOMITANT MEDICAL PRODUCTS: CP114831 - RS SIDE EXP DSTL FMRL LT - 270650 178363 - CPS XS SHT SPDL W PINS - 235950 178552 - CPS SHORT ANCHOR PLUG - 952730 161035 - OSS RS AXLE - 538210 161034 - OSS RS POLY FEM BUSHING - 738370 161037 - OSS RS NON MOD PLATE - 589350 150476 - OSS POLY TIBIAL BUSHING - 148090 161094 - OSS RS 12MM LS TIBIAL BEARING - 622880 150493 - OSS REINFORCED YOKE - 827180 150478 - OSS POLY LOCK PIN - 148110 178512 - CPS NUT CO-CR-MO ALLOY - 144930 H6: COMPONENT CODE: MECHANICAL (G04) - FEMUR THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN OVER A SPAN OF THE LAST YEAR. THE SURGEON BELIEVED THE EXPANDABLE COMPONENT WAS EXPANDING ON ITS OWN, WITHOUT THE REQUIRED SURGERY TO EXPAND IT. THE PATIENT FELT A POP AND COULD NOT BEAR WEAR. THE PATIENT WAS THEN REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG AND THE SPINDLE LOST BONE IN-GROWTH AT THE BONE INTERFACE AND WAS NO LONGER FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873841 CPS TRANSVERSE PIN 6PK 28MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. 297740 00880304260511

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Hospitalization| R