BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 60 REFOB BONE CMT R-3

    MDR report key: 21313033 · Received February 5, 2025

    Report

    Report Number
    3006946279-2025-00013
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    October 31, 2024
    Report Date
    April 22, 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: B4, B5, G1-2, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: G1-2. 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. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE REVIEW OF INITIAL OPERATIONAL NOTES IDENTIFIED A GOOD ACTIVITY LEVEL, A MEDIAL OSTEOARTHRITIS. SURGERY WAS ASSISTED BY ROSA ROBOT. TRIAL FITTING WAS PERFORMED WITH GOOD RANGE OF MOTION, STABILITY WAS NOTED AND PATELLA WAS WELL TRACKING. FINAL IMPLANT WERE PLACED WITH CEMENT. POST CLOSURE FLEXION OF 130, EXTENSION OF -5 AND STABLE. NO COMPLICATIONS WERE NOTED. THE REVIEW OF REVISION OPERATION NOTES IDENTIFIED A NEGATIVE SYNOVASURE. FIBROSIS WAS REMOVED TO ACCESS TO JOINT SPACE. FEMORAL COMPONENT WAS REMOVED AND REAMING WAS PERFORMED. FULL EXTENSION WAS UNABLE TO GET, ADDITIONAL RESECTION WAS PERFORMED, BUT NOTES REMAINS INADEQUATE. PATIENT WAS MOVED TO TOTAL KNEE REVISION, SO INITIAL TIBIAL COMPONENT AND CEMENT WERE REMOVED. SURGEON WAS ABLE TO OBTAIN ADEQUATE STABILITY AND FULL RANGE OF MOTION. FINAL COMPONENTS WERE CEMENTED, NO COMPLICATIONS WERE NOTED. ADDITIONALLY, RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED 6 VIEWS OF LEFT KNEE ARTHROPLASTY WITHOUT HARDWARE FAILURE OR LOOSENING. QUESTION HETEROTOPIC OSSIFICATION ALONG THE MEDIAL PATELLA. NO FRACTURE SEEN. NO JOINT EFFUSION. OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE. MINIMAL CEMENT SEEN ALONG THE MEDIAL AND LATERAL TIBIAL PLATE AS WELL AS THE FEMORAL COMPONENT. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 7; ITEM# 42502606201; LOT# 65617799. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 10 MM HEIGHT; ITEM# 42511000510; LOT# 65691841. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F; ITEM# 42532007501; LOT# 65469232. 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 TKA. SUBSEQUENTLY, THE PATIENT EXPERIENCED 95 DEGREES OF FLEXION AND 10 DEGREES OF EXTENSION WITH MEDIAL SIDE TIGHTNESS. APPROXIMATELY 7 MONTHS AND 11 DAYS POST-IMPLANTATION, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO MODERATE LIMITATION IN RANGE OF MOTION. ALL COMPONENTS WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64760 OPTIPAC 60 REFOB BONE CMT R-3 BONE CEMENT LOD BIOMET FRANCE S.A.R.L. AX25BF0902 04040029922361

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R SEE H11 NARRATIVE.