BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 4 PMA

    MDR report key: 9161130 · Received October 7, 2019

    Report

    Report Number
    3002806535-2019-00790
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    September 2, 2019
    Report Date
    January 25, 2020
    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
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: MEDICAL PRODUCT: OXF TWIN PEG CMNTLS FMRL SM, CATALOG#: 161473, LOT#: 2409851. MEDICAL PRODUCT: OXFORD CEMENTLESS TIBIA B RM, CATALOG#: US166573, LOT#: R3050463A. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00789-1, 3002806535-2019- 00791-1. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE RIGHT KNEE HAS BEEN TWISTED, CAUSING RIGHT KNEE STRAINING. THIS RESULTED IN PAIN AND SWELLING FROM THIGH TO ANKLE. TREATMENT INCLUDED ANTI-INFLAMMATORIES AND THE USE OF A KNEE BRACE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TWIN PEG CMNTLS FMRL SM CATALOG #: 161473 LOT #: 2409851, MEDICAL PRODUCT: OXFORD CEMENTLESS TIBIA B RM CATALOG #: US166573 LOT #: R3050463A. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00789, 3002806535-2019-00791. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT TWISTED THE RIGHT KNEE WHICH CAUSED KNEE STRAIN. THIS RESULTED IN PAIN AND SWELLING FROM THIGH TO ANKLE. TREATMENT INCLUDED ANTI-INFLAMMATORY MEDICATION AND THE USE OF A KNEE BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955151 OXF ANAT BRG RT SM SIZE 4 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 552060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R