BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 60 REFOB BONE CMT R-3

    MDR report key: 21313035 · Received February 5, 2025

    Report

    Report Number
    3006946279-2025-00014
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    September 16, 2024
    Report Date
    April 11, 2025
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LOD
    UDI-DI
    04040029922361
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B3, B4, B5, G1-2, G3, G6, H2, H4, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: B3, G1-2, H4. D4: THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(6). G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K172408. 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. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE IMPLANTED ZIMMER BIOMET DEVICE AND/OR IS A PROCEDURE RELATED EVENT. 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 - ASSOCIATED MEDICAL DEVICES: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 7; ITEM# 42502606202; LOT# 66439346. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT 10 MM HEIGHT; ITEM# 42521000510; LOT# 66285830. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E; ITEM# 42532007102; LOT# 66530589. G2 - FOREIGN: NETHERLANDS. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 4 MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA (MUA) DUE TO STIFFNESS, DECREASED RANGE OF MOTION (ROM), AND ADHESIONS. ALL COMPONENTS REMAIN IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64762 OPTIPAC 60 REFOB BONE CMT R-3 BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AW25BD1709 04040029922361

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H SEE H11 NARRATIVE