BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 23725888 · Received December 5, 2025

    Report

    Report Number
    3006946279-2025-00127
    Event Type
    Injury
    Date Received
    December 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    00887868214578
    PMA / PMN Number
    K172408
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS COMBINED INITIAL AND FINAL MDR REPORT. D10: BIOMET BC R 1X40 US; ITEM NUMBER#: 110035368; LOT#: AY48AL0703. BIOMET BC R 1X40 US; ITEM NUMBER#: 110035368; LOT#: AY49BL0703. VG 360 UNIV PST FM AUG 70X5; ITEM NUMBER#: 185346; LOT#: 138350. VNGD TI FEM SSK 70MM LT; ITEM NUMBER#: CP113127; LOT#: 795410. BMT SPLINED KNEE STM V2 20X120; ITEM NUMBER#: 148323; LOT#: 855010. BIOMET OFFSET TIBIAL TRAY 71MM; ITEM NUMBER#: 141483; LOT#: 866560. OFFSET TIB TRAY NEUT ADAPTOR; ITEM NUMBER#: 141489; LOT#: 146410. BMT SPLINED KNEE STM V2 20X80; ITEM NUMBER#:148310; LOT#: 102900. UNKNOWN BEARING ITEM NUMBER#: UNKNOWN; LOT#: UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS AND RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW OF THE FIRST REVISION NOTES THAT TOOK PLACE IDENTIFIED NO CONTRIBUTING FACTORS TO THE EVENT. THE STABILITY AND RANGE OF MOTION WERE ACHIEVED WITH DEFINITIVE IMPLANTS. 2 WEEKS FOLLOW-UP VISIT NOTES STATES AN IMPROVEMENT IN PAIN AND AN INCREASED ACTIVITY LEVEL. INCISION HEALED NICELY WITHOUT SIGN OF INFECTION. EXCELLENT OVERALL ALIGNMENT AND STABILITY. THERE WAS NO EVIDENCE OF EARLY SUBSIDENCE, LOOSENING, FRACTURE OR IMPLANT COMPLICATION. 3 MONTHS POST-OP, PATIENT HAS A FEELING OF A VICE AROUND HER KNEE. IT WAS NOT POSSIBLE TO DETERMINE IF IT WAS INFLAMMATION OR SCAR TISSUE. A CORTISONE SHOT WAS OFFERED, AND CELEBREX HAS BEEN PRESCRIBED. PATIENT REPORTED FLEXION MOVEMENTS QUITE PAINFUL TO FORCE GREATER ROM. NO FALL OR TRAUMA WERE REPORTED. 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 A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. AT FOLLOW-UP VISIT A CORTISONE SHOT WAS OFFERED AND CELEBREX HAS BEEN PRESCRIBED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867801 BIOMET BC R 1X40 US BONE CEMENT LOD BIOMET FRANCE S.A.R.L. I0605Y37BA 00887868214578

    Patients

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