BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN-PEG CMNTD FEM SM PMA

    MDR report key: 15500503 · Received September 28, 2022

    Report

    Report Number
    3002806535-2022-00391
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 6, 2022
    Report Date
    January 5, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279438228
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICE: OXF UNI TIB TRAY SZ C LM PMA ITEM#: 154722 LOT#: 013320, OXF ANAT BRG LT SM SIZE 4 PMA ITEM#: 159541 LOT#: 464920, PULSAVC PLUS FAN SPRAY KIT INT ITEM#: 00-5150-475-01 LOT#: 64826482, QUICK-VAC MIXING BOWL SINGLE ITEM#: 00-5049-001-00 LOT#: 56518519, OXF SAWBLADE STRYKER CMNTD 3PK ITEM#: 506298 LOT#: 362651. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2022-00393 AND 3002806535-2022-00394.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCTS WERE RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND WEAR APPROXIMATELY ONE AND A HALF (1.5) YEAR POST OP. 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
    2174483 OXF TWIN-PEG CMNTD FEM SM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 649630 05019279438228

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization| R