BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS RS AXLE

    MDR report key: 8435420 · Received March 20, 2019

    Report

    Report Number
    0001825034-2019-01293
    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
    K021260
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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: 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 - 01294; 0001825034 - 2019 - 01295; 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
    231454 OSS RS AXLE PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 282720

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R