BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET BC R 1X40 US

    MDR report key: 19545784 · Received June 17, 2024

    Report

    Report Number
    3006946279-2024-00031
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    September 8, 2023
    Report Date
    July 11, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. . ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS SCAR TISSUE WITHIN OR SURROUNDING A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM SURGICAL IMPLANTATION OF NEW JOINT REPLACEMENT AS WELL AS FROM PREVIOUS INJURIES OR SURGICAL PROCEDURES. SCAR TISSUE FORMATION IS A NORMAL HEALING RESPONSE; HOWEVER, THE BUILDUP OF SUCH CAN RESULT IN PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND DIFFICULTY PROPERLY AMBULATING. IF EXCESS SCAR TISSUE DEVELOPS, CONSERVATIVE MEASURES SUCH AS EXERCISES OR PHYSICAL THERAPY WOULD BE ATTEMPTED FIRST. IF THESE ATTEMPTS FAIL, SURGICAL INTERVENTION SUCH AS MANIPULATION UNDER ANESTHESIA, ARTHROSCOPIC ARTHROLYSIS, OR OPEN ARTHROTOMY WOULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE AND RESTORE JOINT FUNCTION. 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: ITEM #42-5028-060-01; LOT #65561098; FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS. ITEM #00-5954-037-01; LOT #64648962; TIBIAL TRAY FIXED BEARING SIZE 3 DO NOT USE WITH ARTICULAR SURFACE THICKNESSES GREATER THAN 17 MM. ITEM #00-5952-030-14; LOT #64753797; ARTICULAR SURFACE USE WITH PLATE 3,4 SIZE YELLOW/C-H 14 MM HEIGHT. ITEM #00-5972-065-32; LOT #65937727; ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS. 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.

    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 PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA DUE TO STIFFNESS AND ARTHROFIBROSIS POST IMPLANTATION. DURING THE PROCEDURE THE SURGEON WAS ABLE TO BREAK UP ADHESIONS AND SCAR TISSUE INCREASING RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310902 BIOMET BC R 1X40 US BIOMET BONE CEMENT R LOD BIOMET FRANCE S.A.R.L. N/A AX46BI1606 00887868214578

    Patients

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