BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BRG RT X-SM 3MM PMA

    MDR report key: 21812502 · Received April 10, 2025

    Report

    Report Number
    3002806535-2025-00157
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 20, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: OXF UNI TIB TRAY SZA RM; ITEM# 154719; LOT# 1905816. OXFORD UNI TWIN-PEG FEMORAL XS; ITEM# 166940; LOT# 1760982. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H11. CORRECTED DATA: H6 DEVICE CODE: ADDITIONAL CODE ADDED. VISUAL EXAMINATION OF THE PRODUCT RETURN SHOWS THAT THE COMPLAINT OF A BROKEN/FRACTURED IMPLANT IS CONFIRMED, ALL PIECES RETURNED. IN ADDITION TO FRACTURE, ARTICULAR AND DISTAL SURFACES SHOW PITTING AND ARTICULAR SURFACE SHOWS EVIDENCE OF DELAMINATION. FRACTURE ANALYSIS SHOWS THAT THE FRACTURE OF THE UNICONDYLAR BEARING WAS POSSIBLY CAUSED BY OVERLOADING, POSSIBLY EXACERBATED BY DELAMINATION WHICH OCCURRED OVER THE LONG TERM AS A RESULT OF OXIDATION AND THE RESULTING EMBRITTLEMENT. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THREE VIEWS OF THE RIGHT KNEE DEMONSTRATE A MEDIAL COMPARTMENT HEMI ARTHROPLASTY WITH NARROWING OF THE JOINT SPACE CONSISTENT WITH POLYETHYLENE WEAR OR BREAKAGE. SIZING IS APPROPRIATE. POSSIBLE POLYETHYLENE WEAR OR BREAKAGE THAT WOULD LEAD TO A REVISION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. THE RETURNED IMPLANT CONFIRMED THE REPORTED EVENT OF THE FRACTURE. THERE WAS ALSO ADDITIONAL EVIDENCE OF SURFACE PITTING AND DELAMINATION. FRACTURE ANALYSIS INDICATED THAT OVERLOADING AND LONG-TERM OXIDATION WITH EMBRITTLEMENT ARE POSSIBLE CONTRIBUTING FACTORS. HOWEVER, 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 APPROXIMATELY 14 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO BEARING FRACTURE. DUE DILIGENCE IS CURRENTLY IN PROGRESS FOR THIS COMPLAINT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF 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
    1816489 OXFORD ANAT BRG RT X-SM 3MM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. 1410613

    Patients

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