BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 67MM

    MDR report key: 8452836 · Received March 26, 2019

    Report

    Report Number
    0001825034-2019-01063
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    February 28, 2019
    Report Date
    October 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED LOCKING BAR SHOWED EXCESSIVE WEAR WITH DEEP NICKS. A SMALL PIECE OF THE LOCKING BAR WAS FRACTURED BUT WAS NOT RETURNED. DIMENSIONAL ANALYSIS SHOWS THE LOCKING BAR IS OUT OF SPECIFICATIONS. THE BAR MATERIAL WAS VERIFIED. THE SEM REPORT FOR FRACTURED LOCKING BAR STATES THAT THE FRACTURE SURFACE APPEARED HEAVILY SMEARED WITH SUSPECTED BIOLOGICAL DEBRIS ATTACHED TO IT. NO FRACTURE ARTIFACTS IDENTIFIED ON THE FRACTURE THAT WOULD DICTATE THE MODE OF THE FRACTURE. ANALYSIS OF THE LOCKING BAR DETERMINED THAT THE LOCKING BAR CONTACT MARK & DEFORMATION OBSERVATIONS ARE CONSISTENT WITH THE BAR NOT BEING FULLY ENGAGED WITH THE TIBIAL TRAY. HOWEVER, IT CANNOT BE CONFIRMED WITH CERTAINTY WHETHER THE REPORTED LOCKING BAR DISSOCIATION OCCURRED DUE TO IMPROPER INSERTION. ALSO THE MODE OF FRACTURE COULD NOT BE DETERMINED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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). CONCOMITANT MEDICAL PRODUCTS: BIOMET TIBIAL LOCKING BAR; P/N: 141205, L/N: UNK. REPORT SOURCE- FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN SECONDARY TO THE LOCKING BAR DISASSOCIATING FROM THE TIBIAL TRAY APPROXIMATELY ONE YEAR POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246133 BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J6231068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R