BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 9489914 · Received December 18, 2019

    Report

    Report Number
    0001822565-2019-05351
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    November 25, 2019
    Report Date
    March 27, 2020
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED VIA ALLIANCE PARTNER AND THE REPORTED EVENT WAS NOT CONFIRMED. THE REPORTED BONE CEMENT IS AN ALLIANCE PARTNER PRODUCT AND THE ZIMMER BIOMET ALLIANCE PARTNER IS RESPONSIBLE FOR PERFORMING THE INVESTIGATION IN ACCORDANCE WITH THE DISTRIBUTION OR QUALITY AGREEMENT. THE REVIEW OF QUALITY RECORDS SHOWED THAT THE BATCH WAS PREPARED IN ACCORDANCE WITH THE REQUIREMENTS OF OUR QUALITY MANAGEMENT SYSTEM AND ALL QUALITY CONTROL TESTS HAVE BEEN PASSED SUCCESSFULLY. BASED ON THE KNOWLEDGE AND INFORMATION AVAILABLE TO US, WE CANNOT IDENTIFY A PRODUCT DEFICIENCY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IMPLANT DATE: 2006. MEDICAL PRODUCTS: STEMMED NONAUGMENTABLE TIBIAL COMPONENT; P/N: 00598605701, L/N: 60594736, PALACOS R 1X40 SINGLE; P/N: 00111214001, L/N: UNK, PALACOS R 1X40 SINGLE; P/N: 00111214001, L/N: UNK. FEMORAL COMPONENT OPTION SIZE G; P/N: 00596401752, L/N: 60567348, ARTICULAR SURFACE; P/N: 00596205012, L/N: 60509426, ALL POLY PATELLA; P/N: 00597206529, L/N: 60574737. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0002648920 - 2019 - 00902, 0001822565 - 2019 - 05347, 0001822565 - 2019 - 05351. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 13 YEARS POST-IMPLANTATION DUE TO PAIN AND TIBIA LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285138 PALACOS R 1X40 SINGLE BONE CEMENT LOD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R