BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS POLY TIBIAL BUSHING

    MDR report key: 8435426 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-01295
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 15, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K002757
    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 REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    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: OSS RS 12MM LS TIBIAL BEARING; P/N: 161094, L/N: 482080; OSS RS 3 CM RESURF FMR; P/N: 161006, L/N: 230600; OSS CEMENTED IM STEM; P/N: 150359, L/N: 902920; OSS RS AXLE; P/N: 161035, L/N: 282720; OSS RS POLY FEM BUSHINGS; P/N: 161034, L/N: 373910; OSS POLY TIBIAL BUSHING; P/N: 150476, L/N: 464670; OSS REINFORCED YOKE; P/N: 150493, L/N: 682430. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01047; 0001825034 - 2019 - 01037; 0001825034 - 2019 - 01036; 0001825034 - 2019 - 01293; 0001825034 - 2019 - 01294; 0001825034 - 2019 - 01296. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF RANGE OF MOTION APPROXIMATELY TWO YEARS 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
    231672 OSS POLY TIBIAL BUSHING PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 464670

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R