BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC POSTERIOR LIPPED PRI 10X75

    MDR report key: 8091779 · Received November 20, 2018

    Report

    Report Number
    0001825034-2018-10843
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    November 5, 2018
    Report Date
    July 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K781294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTION HAS BEEN CORRECTED: SEX WAS PREVIOUSLY REPORTED AS FEMALE, HOWEVER, DUE TO LIMITED INFORMATION, THE PATIENT'S GENDER CANNOT BE CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. X-RAY EVALUATION REVIEW BY THIRD PARTY HCP CONFIRMS OSTEOLYSIS AT THE LATERAL TIBIAL TRAY/PLATEAU OF THE RIGHT KNEE ARTHROPLASTY. THERE IS LUCENCY AT THE FAR LATERAL ASPECT OF THE TIBIAL TRAY AND AT THE CEMENT-BONE INTERFACE AT THE LATERAL TIBIAL PLATEAU. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: AGC ANATOMIC INTERLOCK FEMORAL, CATALOG #: 152834, LOT #: 905730. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT UNDERWENT RIGHT REVISION DUE TO WEAR CAUSED BY OSTEOLYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN AGC FEMUR, UNKNOWN AGC TIBIAL TRAY, UNKNOWN AGC BEARING. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 10839 , 0001825034 - 2018 - 10843. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND 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 LEFT KNEE REVISION SURGERY OF FEMUR AND TIBIAL TRAY DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931480 AGC POSTERIOR LIPPED PRI 10X75 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 493550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R