BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT SM SIZE 3 PMA

    MDR report key: 16608272 · Received March 24, 2023

    Report

    Report Number
    3002806535-2023-00080
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 26, 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
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. INSTABILITY OF THE POLYETHYLENE BEARING AND ARTHRITIC CHANGES IN THE LATERAL AND PATELLOFEMORAL COMPARTMENTS, EXTENSIVE SCARRING AND THE POLYETHYLENE BEARING WAS DISLOCATED POSTERIORLY. WITH THE AVAILABLE INFORMATION, 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF TWIN-PEG CMNTD FEM SM PMA ITEM# 161468; LOT# 265800. OXF UNI TIB TRAY SZ D RM PMA ITEM# 154725; LOT# 942050. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER INITIAL RIGHT PARTIAL KNEE SURGERY, THE PATIENT UNDERWENT A CONVERSION TO A TOTAL KNEE ARTHROPLASTY DUE TO POLY DISLOCATION, PAIN, LIMITED RANGE OF MOTION, SWELLING, CLUNKING NOISE WHEN GETTING OUT OF BED, INSTABILITY OF THE POLYETHYLENE, RADIOGRAPHIC EVIDENCE OF MOBILE BEARING POSTERIOR KNEE WITH COLLAPSE OF THE MEDIAL COMPARTMENT WITH METAL-ON-METAL. DURING THE REVISION, EXTENSIVE SCARING WAS NOTED, THE POLY WAS FOUND DISLOCATED POSTERIORLY, AND ALL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS. 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
    521981 OXF ANAT BRG RT SM SIZE 3 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 055780 05019279786145

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H