BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 3 PMA

    MDR report key: 18354152 · Received December 19, 2023

    Report

    Report Number
    3002806535-2023-00438
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    November 29, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786145
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE EVENT IS A DUPLICATE OF (B)(4). THIS EVENT HAS BEEN REPORTED IN (B)(4). GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: OXF UNI TIB TRAY SZ B RM PMA; ITEM# 154721; LOT# 120460 OXF TWIN-PEG CMNTD FEM SM PMA; ITEM# 161468; LOT# 857450 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535 - 2023 - 00436 3002806535 - 2023 - 00439 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED AS THE EVENT IS A DUPLICATE OF (B)(4). THIS EVENT HAS BEEN REPORTED IN (B)(4). GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A UNI KNEE ARTHROPLASTY AND APPROXIMATELY 5 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE LOOSENING OF THE IMPLANT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459366 OXF ANAT BRG RT SM SIZE 3 PMA OXFORD HXLPE BEARINGS NRA BIOMET UK LTD. N/A 242190 05019279786145

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE.