BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS YOKE SET

    MDR report key: 7428842 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02577
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 6, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPONENT DID NOT CONTRIBUTE TO THE REPORTED EVENT. THIS COMPONENT WAS ONLY REMOVED TO BE ABLE TO REMOVE THE COMPONENTS THAT CAUSED THE ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: OSS TIBIAL BEARING, CATALOG #: 161096, LOT #: 395390; OSS AXLE AND BUSHING, CATALOG #: CP116410, LOT #: 753570; OSS DISTAL FEMORAL COMPONENT, CATALOG #: CP116407, LOT #: 752420; OSS MODULAR TIBIAL COMPONENT, CATALOG #: CP116408, LOT #: 752690; OSS POROUS STEM, CATALOG #: 150395, LOT #: 862660; OSS POROUS STEM, CATALOG #: 150385, LOT #: 150385. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04410, 0001825034-2018-02576, 0001825034-2018-02577. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LEG LENGTH DISCREPANCY. THE POLYETHYLENE BEARING AND ASSEMBLY WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272814 OSS YOKE SET PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 753320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R