BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD ANAT BRG LT X-SM SZ 3 PMA

    MDR report key: 21749821 · Received April 2, 2025

    Report

    Report Number
    3002806535-2025-00140
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 7, 2025
    Report Date
    August 28, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, B7, G3, G6, H1, H2, H3, H11. THE FOLLOWING SECTION WAS CORRECTED: H6. 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 ¿ 166570, OXF UNI CMNTLS TIB SZ AA LM, LOT # 3220112. 154912, OXF PH3 CEMENTLESS FEM SZ XSM, LOT # 3093630. G2 ¿ FOREIGN ¿ GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2, B4, B5, G3, G6, H1, H2, H3, H11. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H11. THE FOLLOWING SECTION WAS CORRECTED: H4. VISUAL EXAMINATION OF THE PRODUCT RETURN SHOWS THAT THE BEARING EXHIBITS SIGNS OF USE (WEAR) AND CONFIRMING COMPLAINT OF FRACTURE, NOT ALL PIECES WERE RETURNED. PERFORMED DIMENSIONAL ANALYSIS RESULTS ARE WITHIN SPECIFICATION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW IDENTIFIED MECHANICAL COMPLICATION DUE TO AN OXFORD TYPE MEDIAL CARRIAGE PROSTHESIS WITH INLAY FRACTURE. X-RAY CONFIRMED IMPLANT FRACTURE. INLAY BROKE CENTRALLY INTO 2 PARTS WHICH WERE REMOVED COMPLETELY. NEW INLAY WAS PLACED WITH BALANCE OF THE JOINT AND CORRECT FEMORAL PATELLAR ARTICULATION WITH NO COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A CONTRIBUTING FACTOR MAY HAVE BEEN THE PATIENT¿S FALL, WHICH OCCURRED DUE TO AN UNKNOWN CAUSE, AS NO REASON FOR THE FALL WAS MENTIONED. 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 REVISION SURGERY OF THE LEFT KNEE TEN YEARS AND EIGHT MONTHS POST IMPLANTATION DUE TO A BEARING FRACTURE AFTER A FALL DUE TO UNKNOWN CAUSE. THE INLAY WAS EXCHANGED WITHOUT COMPLICATIONS. THE FEMUR AND TIBIA COMPONENTS REMAINED IMPLANTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE LEFT KNEE TEN YEARS AND EIGHT MONTHS POST IMPLANTATION DUE TO A BEARING FRACTURE AFTER A FALL. 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.

    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
    2333755 OXFORD ANAT BRG LT X-SM SZ 3 PMA PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL NRA BIOMET UK LTD. 3226998

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention| H SEE H11 NARRATIVE