BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 7 PMA

    MDR report key: 23632775 · Received November 24, 2025

    Report

    Report Number
    3002806535-2025-00547
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 29, 2025
    Report Date
    March 6, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786251
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCTS WERE RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THEREPORTED PART AND LOT COMBINATIONS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE RADIOLOGIST. THE REVIEW IDENTIFIED A PHOTOGRAPH OF COMPUTER SCREEN OF ANTEROPOSTERIOR VIEW OF THE RIGHT KNEE SHOWING A UNICOMPARTMENTAL ARTHROPLASTY OF THE KNEE INVOLVING THE MEDIAL COMPARTMENT. THIN RADIOLUCENCY (LESS THAN 1 MM) AT THE BONE CEMENT INTERFACE AROUND THE TIBIAL COMPONENT IS MARKED BY ARROWS ON THE IMAGE. MILD OSTEOARTHRITIS IS NOTED IN THE LATERAL COMPARTMENT IN THE FORM OF OSTEOPHYTE FORMATION WITHOUT JOINT SPACE NARROWING. THERE APPEARS TO BE RELATIVE VALGUS ALIGNMENT OF THE KNEE COMPONENTS, HOWEVER A STANDING BONE LENGTH VIEW OF THE EXTREMITIES WOULD BE NECESSARY TO PROVIDE DEFINITIVE MEASUREMENTS. UNICOMPARTMENTAL ARTHROPLASTY OF THE LEFT KNEE. THIN RADIOLUCENCY AT THE BONE CEMENT INTERFACE AROUND THE TIBIAL COMPONENT IS INDETERMINATE FOR LOOSENING AND MAY REPRESENT FIBROUS INGROWTH-COMPARISON WITH PRIOR RADIOGRAPHS WOULD BE HELPFUL FOR COMPARISON TO EVALUATE FOR CHANGE OVER TIME. NO OTHER SIGNS OF LOOSENING OR ACUTE HARDWARE COMPLICATION ARE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT 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). D10 ¿ ITEM 154719; OXF UNI TIB TRAY SZA RM; LOT: 7182178. ITEM 166942; OXFORD UNI TWIN-PEG FEMORAL MD; LOT: J71788899. G2 ¿ FOREIGN ¿ AUSTRALIA. 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 THE PATIENT HAD AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THEY UNDERWENT A REVISION SURGERY DUE TO INSTABILITY, APPROXIMATELY 3 YEARS, 3 MONTHS POSTOPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263307 OXF ANAT BRG RT MD SIZE 7 PMA KNEE PROSTHESIS NRA BIOMET UK LTD. 6876412 05019279786251

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R SEE H11 NARRATIVE.