BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT G-HV BONE CEMENT 40G

    MDR report key: 11704419 · Received April 21, 2021

    Report

    Report Number
    0001825034-2021-01164
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    January 17, 2019
    Report Date
    August 20, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K051532
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. RADIOGRAPHS INDICATED RADIOLUCENT LINES AROUND MEDIAL TIBIAL AND PROXIMAL TIBIA CONCERN FOR POTENTIAL LOOSENING. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: HISTORY OF PAIN, DIFFICULTY AMBULATING AND RECENT REVISION OF LEFT KNEE. RIGHT TKA DUE TO TIBIAL LOOSENING, REVISED FEMORAL AND TIBIAL COMPONENTS. SYNOVITIS WAS SIGNIFICANT, AND SYNOVECTOMY PERFORMED. TIBIA COMPONENT GROSSLY LOOSE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN & TIBIA LOOSENING. THE TIBIAL, FEMORAL, ARTICULAR SURFACE COMPONENTS AND BONE CEMENT WERE ALL REMOVED. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FEMUR REF: (B)(4), LOT: 598710 . TIBIAL PLATE REF: (B)(4), LOT: J3286679. LOCKING BAR REF: (B)(4), LOT: 954290. POSTERIOR STABILIZED LINER REF: (B)(4), LOT :196620. PATELLAR BUTTON REF: (B)(4), LOT: 870250. BIOMET COBALT G-HV CEMENT REF: (B)(4), LOT: 221710 & 062660. 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: 0001825034-2021-01165. 0001825034-2021-01166.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO RADIOGRAPHIC LOOSENING OF THE TIBIA COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601435 COBALT G-HV BONE CEMENT 40G PROSTHESIS, HIP LOD ZIMMER BIOMET, INC. N/A 578730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R