BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AVL TIB BEARING 12MM

    MDR report key: 11739339 · Received April 28, 2021

    Report

    Report Number
    0001825034-2021-01281
    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
    00880304456136
    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

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE LOCKING RING FRACTURE IS WHAT CAUSED THE YOKE TO DISASSOCIATE FROM THE TIBIAL TRAY. THEREFORE, THE LOCKING RING IS THE ONLY REPORTABLE ITEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED IN ERROR. THE LOCKING RING FRACTURE IS WHAT CAUSED THE YOKE TO DISASSOCIATE FROM THE TIBIAL TRAY. THEREFORE, THE LOCKING RING IS THE ONLY REPORTABLE ITEM. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2021-01278, 0001825034-2021-01279, 0001825034-2021-01280, 0001825034-2021-01282, 0001825034-2021-01283, 0001825034-2021-01284. CONCOMITANT MEDICAL PRODUCTS: OSS AVL TIBIAL LOCK RING, ITEM# 161073, LOT# 466660. OSS AVL YOKE 12MM, ITEM# 161075, LOT# 382130. OSS AVL MOD TIB PLATE OSS TAPE, ITEM# 161065, LOT# 690080. 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
    635265 OSS AVL TIB BEARING 12MM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 809890 00880304456136

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R