BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIPAC 80 REFOB BONE CMT R-3

    MDR report key: 23955420 · Received January 5, 2026

    Report

    Report Number
    3006946279-2026-00002
    Event Type
    Death
    Date Received
    January 5, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    04040029922385
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 ¿ FOREIGN ¿ JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H10, H11. THE REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LACK OF PRODUCT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A RETAIN SAMPLE OF BATCH HAS BEEN TESTED IN THE LABORATORY UNDER STANDARDIZED CONDITIONS. NO UNUSUAL HARDENING TEMPERATURE WAS NOTICED DURING CEMENT SETTING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. REVIEW OF THE INSTRUCTION THAT AFTER PREPARATION OF THE PROSTHESIS BED OR DIRECTLY AFTER THE IMPLANTATION OF THE CEMENT AND PROSTHESIS, PRESSURE RISE IN THE BONE BED MAY CAUSE A TEMPORARY FALL IN BLOOD PRESSURE. IN ADDITION TO HYPOTENSION, PULMONARY EMBOLISM AND CARDIAC ARREST, WITH THEIR POTENTIALLY FATAL CONSEQUENCES, HAVE BEEN ENCOUNTERED IN RARE CASES. THESE CARDIOVASCULAR AND RESPIRATORY SIDE EFFECTS, KNOWN AS THE IMPLANTATION SYNDROME, ARE MAINLY CAUSED BY INFILTRATION OF BONE MARROW CONSTITUENTS INTO THE VENOUS VASCULAR SYSTEM. THE SITE OF THE PROSTHESIS SHOULD THEREFORE BE RINSED THOROUGHLY WITH AN ISOTONIC SOLUTION (E.G. PHYSIOLOGICAL SALINE) BEFORE IMPLANTATION. TO MINIMIZE THE PRESSURE, INCREASE IN THE BONE BED DURING IMPLANTATION OF THE CEMENT AND THE PROSTHESIS, SUFFICIENT DRAINAGE IS RECOMMENDED. IN THE PRESENCE OF PULMOCARDIOVASCULAR DISTURBANCES, THE BLOOD LOSS SHOULD BE MONITORED AND ANAESTHESIOLOGICAL MEASURES MAY BE REQUIRED E.G., IN THE EVENT OF ACUTE RESPIRATORY FAILURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DURING A BHA PROCEDURE USING CEMENT WITH ANOTHER COMPANY¿S PRODUCT, THE PATIENT DEVELOPED IMMEDIATE HYPOTENSION AFTER CEMENT INSERTION. ELEVATING THE PATIENT¿S HEAD LED TO SLIGHT IMPROVEMENT, AND SURGERY CONTINUED, BUT THE PATIENT LATER DETERIORATED AND DIED. THE SURGEON CONSIDERED THIS A TYPICAL PULMONARY EMBOLISM ASSOCIATED WITH CEMENTING AND NOTED THE CEMENT TOOK ABOUT 15 MINUTES TO SET, SUGGESTING POSSIBLE RAPID INSERTION. POSTOPERATIVE INFORMATION INDICATED THE ANESTHESIOLOGIST WAS OFF-DUTY AND VITAL SIGNS WERE NOT MONITORED UNTIL THE PATIENT WORSENED. ALTHOUGH PULMONARY EMBOLISM WAS LISTED AS THE CAUSE OF DEATH, THE FAMILY DECLINED POSTMORTEM IMAGING OR TESTS, SO THE DIAGNOSIS COULD NOT BE CONFIRMED. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29391 OPTIPAC 80 REFOB BONE CMT R-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. AU13CB2810 04040029922385

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| D SEE H11 NARRATIVE