BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS POLY TIBIAL BEARING 12

    MDR report key: 10494774 · Received September 4, 2020

    Report

    Report Number
    0001825034-2020-03419
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    August 25, 2020
    Report Date
    January 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K052685
    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IMPLANT FRACTURE WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED BEARING FOUND DAMAGE (GOUGES AND SCRATCHES) AND IS CRACKED/FRACTURED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE ARTICULAR SURFACE FRACTURE. THE ROOT CAUSE OF THE INFECTION WAS DETERMINED TO NOT BE DEVICE RELATED. 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). UDI #: (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM 161034 LOT 738430; ITEM 150476 LOT 702490; ITEM 150478 LOT 772840; ITEM 150493 LOT 213480; ITEM 161035 LOT 258530; ITEM 150805 LOT 778110; ITEM 161013 LOT 324480; ITEM 150367 LOT 742980; ITEM 3020830401-3 LOT 833FAE0802; ITEM 3020830401-3 LOT 833FAE0802; ITEM 3020830401-3 LOT 833FAE0802. 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 THAT PATIENT UNDERWENT OSS PROCEDURE AND SUBSEQUENTLY ELEVEN MONTHS AFTER THE PROCEDURE THE PATIENT WAS REVISED DUE TO PRECISE WEAR OF POLYETHYLENE AND INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961864 OSS RS POLY TIBIAL BEARING 12 PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 355510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R