BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL TIBIAL LOCK RING

    MDR report key: 11739283 · Received April 28, 2021

    Report

    Report Number
    0001825034-2021-01278
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    August 14, 2019
    Report Date
    May 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00880304456181
    PMA / PMN Number
    K051570
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01281, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284. MEDICAL PRODUCT: OSS AVL YOKE 12MM ITEM# 161075 LOT# 382130; OSS AVL MOD TIB PLATE OSS TAPE ITEM# 161065 LOT# 690080; OSS AVL TIB BEARING 12MM ITEM# 161068 LOT# 809890; OSS TIB BLK AUG 10X63/67 UNIV ITEM# 150426 LOT# 105590; OSS AVL POLY TIB BUSHING SET ITEM# 161071 LOT# 490920; OSS POLY FEMORAL BUSHINGS ITEM# 150477 LOT# 499870. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FIVE MONTHS¿ POST-IMPLANTATION DUE TO LOCKING NUT FRACTURED IN TWO PIECES AND ALLOWED PISTON TO DISENGAGE FROM THE TIBIAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633315 OSS AVL TIBIAL LOCK RING PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 466660 00880304456181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R