BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 79MM

    MDR report key: 18696724 · Received February 13, 2024

    Report

    Report Number
    0001825034-2024-00412
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    December 16, 2021
    Report Date
    July 23, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2024-00414 0001825034-2024-00415 0001825034-2024-00416. D10-MEDICAL PRODUCT SERIES A ASYMMETRIC PAT 34X8.5 ITEM# 184793 LOT# 802020 VANGUARD CR ILOK FEM-RT 72.5 ITEM# 183013 LOT# J3868275 VNGD CR TIB BRG 12X79/83 ITEM# 183462 LOT# 242560 H3- 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SEVERE PAIN WITH TWENTY-DEGREE EXTENSOR LAG. ASEPTIC FEMORAL LOOSENING WITH EXTENSOR MECHANISM RUPTURE, STIFFNESS/ROM, QUADRICEPS TENDON RUPTURE, SCAR TISSUE BOTH PROXIMALLY AND DISTALLY. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT HAS BEEN CONFIRMED BY THE MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR AND FIVE MONTHS POST IMPLANTATION DUE TO ASEPTIC FEMORAL LOOSENING AND A QUADRICEP TENDON RUPTURE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233288 BIOMET CC CRUCIATE TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6687109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H