BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD TIBIAL COMPONENT

    MDR report key: 6558971 · Received May 10, 2017

    Report

    Report Number
    3002806535-2017-00313
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    October 17, 2016
    Report Date
    January 22, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00311-1 AND 3002806535-2017-00312-1.

    Additional Manufacturer Narrative · 1

    REFERENCE: CMP-(B)(4). MEDICAL PRODUCT: OXFORD BEARING, ITEM # 159547, LOT # 644680, OXFORD FEMORAL COMPONENT, ITEM # 161474, LOT # R249493A. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P010014. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED. 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 3002806535-2017-00311 AND 3002806535-2017-00312.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT REPORTED PAIN IN THEIR KNEE AFTER RETURNING TO WORK. NO REVISION PROCEDURE IS BEING PLANNED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338024 OXFORD TIBIAL COMPONENT PROSTHESIS, KNEE NRA BIOMET UK LTD. R3050461A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SEE H10