BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD MP SLOT POST CUT GD SML

    MDR report key: 23755660 · Received December 9, 2025

    Report

    Report Number
    3002806535-2025-00568
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    UDI-DI
    05019279440016
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT FOUND IT TO EXHIBIT SIGNS OF REPEATED USE WITH THE CUT SLOT SHOWING WEAR/BLADE MARKS. THE CUT GUIDE WAS MISSING BOTH THE 2.5 DIA. PIN (ITEM # 37-100025-4) AND THE RED POMALUX PLUG (ITEM # 32-420325-4) NEITHER SUBCOMPONENT WAS RETURNED. 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 INTRAOPERATIVE FLUOROSCOPIC IMAGES OF THE KNEE SHOW CHANGES OF NONCOMPARTMENTAL ARTHROPLASTY. SOME OF THE IMAGES SHOW AN OVAL METALLIC DENSITY PROJECTING OVER THE LATERAL COMPARTMENT NEAR THE INTERCONDYLAR NOTCH, WHICH COULD CORRESPOND TO A RETAINED FOREIGN BODY AS SUGGESTED IN THE GIVEN HISTORY. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE IS INADEQUATE FIXATION OF THE PIN. ASSEMBLY REQUIREMENTS IN THE DESIGN DRAWING HAVE BEEN UPDATED TO ADDRESS THIS ISSUE. 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). G2: FOREIGN - EVENT OCCURRED IN CHINA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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 UNDERWENT REOPERATION FOR DEBRIDEMENT AND EXPLORATION ONE WEEK POST INITIAL SURGERY DUE TO A METAL RADIOLUCENT SHADOW REVEALED ON AN X-RAY PERFORMED FOUR DAYS POST IMPLANTATION. DURING THE PROCEDURE, THE OBJECT WAS IDENTIFIED AS THE METAL PIN FROM THE FEMORAL POSTERIOR CONDYLE OSTEOTOMY INSTRUMENT WITHIN A UNICONDYLAR ARTHROPLASTY KIT, AND IT WAS RETRIEVED. NO FURTHER CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED. 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
    2754855 OXFORD MP SLOT POST CUT GD SML ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. ZB140901 05019279440016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H