BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 4

    MDR report key: 15091774 · Received July 25, 2022

    Report

    Report Number
    3002806535-2022-00332
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785940
    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 TWIN-PEG CMNTD FEM MD PMA; ITEM# 161469; LOT# 703020; 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: 3002806535-2022-00331 AND 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). INVESTIGATION RESULTS ARE NOW AVAILABLE. DURING THE INVESTIGATION IT WAS CONCLUDED THAT PRODUCT DID NOT FAIL TO MEET EXPECTATIONS; THE REVISION TOOK PLACE DUE TO PROGRESSION OF ARTHRITIS. GIVEN THIS INFORMATION, THIS COMPLAINT IS NOT REPORTABLE AND THIS MEDWATCH WILL BE VOIDED. PLEASE DELETE THIS REPORT 3002806535-2022-00332 FROM YOUR RECORDS.

    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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570394 OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 4 KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 376980 05019279785940

    Patients

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