BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD BEARING S4

    MDR report key: 8919934 · Received August 22, 2019

    Report

    Report Number
    3002806535-2019-00691
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    April 18, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PROGRESSION OF OA AND PAIN. DURING OPERATION BEARING WAS FOUND TO BE FRACTURED WITH METALLOSIS IN THE JOINT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN OXFORD FEMORAL COMPONENT S L CATALOG #: NOT REPORTED LOT #: NOT REPORTED, MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT S E CATALOG #: NOT REPORTED LOT #: NOT REPORTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00692, 3002806535-2019-00693. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE HOSPITAL THAT A PATIENT UNDERWENT AN INITIAL LEFT KNEE REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO PROGRESSION OF OA AND PAIN. DURING OPERATION BEARING WAS FOUND TO BE FRACTURED WITH METALLOSIS IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716766 UNKNOWN OXFORD BEARING S4 KNEE PROSTHESIS NRA BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R