BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS TIBIAL POLY BEARING

    MDR report key: 8128463 · Received December 4, 2018

    Report

    Report Number
    0001825034-2018-11031
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 5, 2018
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : KNE-OSS-FEMORALS-UNK; P/N: UNK, L/N: UNK, KNE-OSS-STEMS-UNK; P/N: UNK, L/N: UNK, KNE-OSS-STEMS-UNK; P/N: UNK, L/N: UNK, KNE-OSS-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : OSS TIBIAL POLY BEARING 16MM; P/N: 150412, L/N: 369490, KNEE-OSS-FEMORAL BUSHINGS-UNK; P/N: UNK, L/N: UNK, KNEE-OSS-TIBIAL BUSHINGS-UNK; P/N: UNK, L/N: UNK, KNEE-OSS-LOCKING PIN-UNK; P/N: UNK, L/N: UNK, KNE-OSS-FEMORALS-UNK; P/N: UNK, L/N: UNK, KNE-OSS-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK, OSS AUGMENT IMPACTOR; P/N: 110018814, L/N: UNK . COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. VISUAL INSPECTION OF EXPLANTED BEARING SHOWS WEAR WITH DEEP NICKS. POLY HAS CHIPPED OFF AT MANY PLACES WITH DELAMINATION AND PITS SEEN. X-RAY REVIEW BY MMI STATES THAT SUBTLE HARDWARE ABNORMALITIES CANNOT BE CLEARLY EVALUATED. NO GROSS FRACTURE OR DISPLACEMENT IDENTIFIED. SCARRING OF THE TIBIAL PLATEAU AS IDENTIFIED CLINICALLY IS NOT CONFIRMED RADIOGRAPHICALLY. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 04188, 0001825034 - 2019 - 04189, 0001825034 - 2019 - 04190.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 8 YEARS POST-IMPLANTATION DUE TO A TENDON/PATELLA ISSUE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIBIAL BEARING WAS PREVIOUSLY DAMAGED. THE LOCKING PIN, BUSHINGS AND TIBIAL BEARING WERE REMOVED AND REPLACED. 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). REPORT SOURCE: FOREIGN: (B)(6). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS AND ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED AND NOTED DURING INSPECTION THE INSERT WAS DAMAGED. SUBSEQUENTLY, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967149 OSS TIBIAL POLY BEARING PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 369490

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R