BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT G-HV BONE CEMENT 40G

    MDR report key: 10749499 · Received October 28, 2020

    Report

    Report Number
    0001825034-2020-03894
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    November 15, 2018
    Report Date
    April 19, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 402283 COBALT G-HV BONE CEMENT 40G 466050, 1294-05-712 DEPUY TIBIAL INSERT 182293, 1294-01-070 DEPUY PRIMARY FEMORAL 3139933, 1294-33-140 DEPUY TIBIAL TAY 8187551, 1294-09-670 DEPUY LCS PATELLA 3549523. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 01116. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING: MECHANICAL FAILURE, LOOSE TIBIAL COMPONENT, RIGHT TKA SEVERE PAIN AND INSTABILITY OF THE KNEE, KNEE TENDS TO COLLAPSE INTO VARUS, X-RAY SHOWED LOOSENING OF THE TIBIAL COMPONENT WITH FAILURE OF CEMENT MANTLE. TIBIAL COMPONENT GROSSLY LOOSE, NO ADHERENCE BETWEEN THE BONE CEMENT AND THE TIBIAL COMPONENT, BONE CEMENT MANTLE WAS QUITE TENUOUS AND THE CEMENT BEING CRACKED AND FISSURED THROUGHOUT. SCAR TISSUE EXCISED, MALPOSITION OF TIBIAL IMPLANT (COMPETITOR DEVICE)NOTED. BONE CEMENT EXCISED, COMPETITOR IMPLANTS PLACED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE 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 THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE BONE CEMENT. 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
    1209795 COBALT G-HV BONE CEMENT 40G BONE CEMENT LOD ZIMMER BIOMET, INC. 466050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R