BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 14169870 · Received April 21, 2022

    Report

    Report Number
    0001822565-2022-01172
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    October 29, 2019
    Report Date
    June 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K030902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 141213 ¿ TIBIA TRAY ¿ 384350, EP-183640 ¿ E1 TIBIA ¿ 943800, CP113642 ¿ VANGUARD FEMORAL ¿ 527780, 141314 ¿ STEM ¿ 267960, 184786 ¿ PATELLA ¿ 477690. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-01173.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY WITH NO COMPLICATIONS. SUBSEQUENTLY PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, SWELLING AND INSTABILITY. CT SHOWS TIBIAL COMPONENT IS INTERNALLY ROTATED BY 25-30 DEGREES. CEMENT NOTED ON BONE AND IMPLANT OF THE TIBIA, NO CEMENT ON THE FEMORAL IMPLANT. IMAGES ASSESSED BUT NOT SENT TO MMI FOR REVIEW AS REVISION OP NOTE PROVIDES SUFFICIENT DICTATION OF FINDINGS. BASED ON THE MISSING PRODUCT DATA NO BATCH RECORD REVIEW COULD BE PERFORMED. THE REVISION WAS NECESSARY BECAUSE A MALALIGNMENT OF THE KNEE COMPONENTS THAT LED TO THE ROTATION OF THE TIBIAL COMPONENT. THE BONE CEMENT HAD NO INFLUENCE ON THIS EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. 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 THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 10 MONTHS POST IMPLANTATION DUE TO PAIN, STIFFNESS, SWELLING, CLICKING AND INSTABILITY. IT WAS NOTED ON A CT REVIEW BY THE SURGEON THAT THE TIBIAL COMPONENT WAS INTERNALLY ROTATED. DURING THE REVISION, IT WAS FOUND THAT THERE WAS NO CEMENT PRESENT ON THE BONE AND TIBIAL IMPLANT WHICH WAS REMOVED EASILY, BUT THE FEMORAL IMPLANT HAD NO CEMENT ATTACHMENT. THE PATELLAR IMPLANT WAS LEFT INTACT AND ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771086 PALACOS R 1X40 SINGLE BONE CEMENT LOD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R