BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL MD

    MDR report key: 21513889 · Received March 4, 2025

    Report

    Report Number
    3002806535-2025-00103
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    February 20, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. D10: ITEM NAME: OXF ANAT BRG RT MD SIZE 4 PMA; ITEM NUMBER: 159576; LOT: 2880651. ITEM NAME: OXF UNI TIB TRAY SZ C RM PMA; ITEM NUMBER: 154723; LOT: UNKNOWN. ITEM NAME: UNKNOWN BONE PALACOS CEMENT; ITEM NUMBER: UNKNOWN; LOT: UNKNOWN. G2: FOREIGN: GERMANY. 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). D4: PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER IS NOT APPLICABLE AS THE LOT NUMBER OF THE DEVICE IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G1-2, G3, G6, H2, H6, H10, H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT EXHIBITS SIGNS OF EXTREME USE (PITS, GOUGES,) AND CONFIRMS THE COMPLAINT IN THAT THE BEARING HAS FRACTURED. IT IS NOT POSSIBLE TO CONFIRM IF ALL PIECES WERE RETURNED DUE TO THE DAMAGE SEEN. ADDITIONALLY, DIMENSIONAL ANALYSIS NOT PERFORMED DUE TO DAMAGE. THE BEARING WAS SENT FOR FURTHER FRACTURE ANALYSIS WHO REPORTED THAT THE FRACTURE IN THE BEARING WAS POTENTIALLY CAUSED BY OVERLOADING WITH POSSIBLE CONTRIBUTING FACTORS OF OXIDATION AND DELAMINATION. BOTH OF THESE MAY HAVE BEEN POSSIBLY EXACERBATED BY THE OVERLOADING, AND ALSO POSSIBLY MISALIGNMENT OF THE BEARING WITH THE TIBIAL TRAY. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST.THE REVIEW IDENTIFIED AN ANATOMIC ALIGNMENT OF THE RIGHT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY WITH PROGRESSIVE POLYETHYLENE WEAR OR FRACTURE AS NOTED. THE IMPLANT FIT AND ALIGNMENT ARE MAINTAINED. BONE QUALITY IS OSTEOPENIC ON ALL IMAGES. THERE IS EVIDENCE OF ADVANCED POLYETHYLENE WEAR OR FRACTURE AS NOTED. ALIGNMENT IS MAINTAINED. THERE IS MARKED OSTEOPENIA ON ALL IMAGES. THE NARROWED MEDIAL COMPARTMENT SPACE IS DUE TO EITHER BEARING WEAR OR FRACTURE, BUT THIS CANNOT BE DISTINGUISHED ON THE RADIOGRAPHS. NO METALLOSIS IS IDENTIFIED. NO ANATOMICAL OR ALIGNMENT FACTORS ARE IDENTIFIED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED THAT THE IMPLANTS ARE FIXED. THE MENISCUS IS BROKEN CENTRALLY AND COMPLETELY SALVAGED. EFFUSION IS CLEAR. SYNOVITIS WITH SYNOVECTOMY. SMALL CENTRAL CARTILAGE DEFECT ON FEMUR LATERALLY IN MAIL LOADING ZONE WITH STABLE CARTILAGE EDGES. NO INTRA-OP COMPLICATIONS/EVENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT UNICOMPARTMENTAL KNEE REVISION DUE TO THE MENISCUS FOUND BROKEN CENTRALLY WITH MINIMAL LOCAL METALLOSIS. DURING THE PROCEDURE NOTED A CLEAR EFFUSION AND SYNOVITIS. THE BEARING WAS EXCHANGED WITHOUT COMPLICATIONS. APPROXIMATELY 12 YEARS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    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
    1331384 OXFORD UNI FEMORAL MD KNEE PROSTHESIS NRA BIOMET UK LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE.