BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA CEMENTED 5 DEGREE

    MDR report key: 8861398 · Received August 5, 2019

    Report

    Report Number
    0001822565-2019-03302
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    May 9, 2016
    Report Date
    February 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K122765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UPDATED: A5, B4, B5, B7, G4, G5, G7 ADDITIONAL: H1, H2, H10 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 03302 - 1

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. INITIAL LEFT TKA OP NOTES DEMONSTRATED THAT THE PATIENT HAD TKA DUE TO OSTEOARTHRITIS. NO INTRAOP COMPLICATIONS NOTED. REVISION OP NOTES DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND PAIN. THE SURGEON WAS UNABLE TO REMOVE THE TIBIAL COMPONENT WITHOUT ANY DIFFICULTY. THE TIBIAL PLATE AND ARTICULAR SURFACE WAS REMOVED AND NEW TIBIAL PLATE, STEM EXTENSION, ARTICULAR SURFACE, AND AUGMENT WERE IMPLANTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS 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

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE 3 YEARS POST IMPLANTATION DUE TO PAIN AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. DURING THE PROCEDURE, THE TIBIAL COMPONENT AND ART SURFACE WERE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    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). MEDICAL PRODUCTS: TIBIA CEMENTED, P/N: 42532006401, L/N: 62258244; FEMUR CEMENTED, P/N: 42500006201, L/N: 62118568; ARTICULAR SURFACE, P/N: 42512400513, L/N: 62197463; ALL-POLY PATELLA CEMENTED, P/N: 42540200032, L/N: 62235042. 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: 0001822565-2019-03302, 0001822565-2019-03324. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE 3 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE TIBIAL COMPONENT AND ART SURFACE WERE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653980 TIBIA CEMENTED 5 DEGREE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62258244

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R