BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT HV BONE CEMENT 40G

    MDR report key: 11725115 · Received April 26, 2021

    Report

    Report Number
    0001825034-2021-01210
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    November 6, 2019
    Report Date
    August 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K051496
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING TIBIAL COMPONENT WAS LOOSE AT THE CEMENT INTERFACE AND WAS EASILY MOBILE AND A THIN FLEXIBLE OSTEOTOME COULD FIT IN BETWEEN THE COMPONENTS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 417200 - OPTIVAC KIT ¿ 0001083195. 94-0023 ¿ DEPUY KNEE - 549156. 96-0101 ¿ DEPUY KNEE - 8279413. 1294-33-125 ¿ DEPUY KNEE - 8256139. 96-2301 ¿ DEPUY KNEE - 8230036. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT. DURING THE REVISION, IT WAS FOUND THAT THE CEMENT DELAMINATED FROM THE TIBIAL COMPONENT AND THE CEMENT MANTEL IN ITS ENTIRETY WAS LEFT ON THE TIBIAL SURFACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623398 COBALT HV BONE CEMENT 40G BONE CEMENT IMPLANT LOD ZIMMER BIOMET, INC. N/A 971770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R