BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS TWIN PEG FEMUR - MEDIUM

    MDR report key: 15091772 · Received July 25, 2022

    Report

    Report Number
    3002806535-2022-00331
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438242
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICE: OXF ANAT BRG LT MD SIZE 4 PMA; ITEM# 159548; LOT# 376980. OXF UNI TIB TRAY SZ C LM PMA; ITEM# 154722; LOT# 810720. OXFORD RESECTION 3PK STRK 6 H; ITEM# 506124; LOT# 948229. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2022 ¿ 00332, 3002806535 - 2022 ¿ 00333. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED THAT ARTHRITIS PROGRESSED TO LATERAL SIDE AND PATIENT NEEDED A TOTAL KNEE REPLACEMENT, THEREFORE THE PATIENT WAS REVISED. PRODUCT DID NOT FAIL TO MEET EXPECTATIONS. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT HAD A PARTIAL KNEE ARTHROPLASTY IMPLANTATION SURGERY AND APPROXIMATELY 8 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARTHRITIS PROGRESSED TO LATERAL SIDE AND PATIENT NEEDED A TOTAL KNEE REPLACEMENT, THEREFORE THE PATIENT WAS REVISED. PRODUCT DID NOT FAIL TO MEET EXPECTATIONS. GIVEN THIS INFORMATION, EVENT IS NOT REPORTABLE; THIS MEDWATCH WILL BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570392 OXFORD PKS TWIN PEG FEMUR - MEDIUM KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 703020 05019279438242

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R