REFOBACIN BONE CEMENT R 1X40-3

Description of Event or Problem

IT WAS REPORTED THAT AN ELDERLY FEMALE PATIENT WITH AN INTERTROCHANTERIC FRACTURE OF THE RIGHT FEMUR UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. DURING THE PROCEDURE, THE BONE CEMENT WAS USED TO SECURE THE JOINT PROSTHESIS. DURING THE SURGERY, THE BONE CEMENT AND PROSTHESIS WERE IMPLANTED AND APPROXIMATELY 1 HOUR LATER, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST, AND IMMEDIATE CARDIOPULMONARY RESUSCITATION AND EMERGENCY INTERVENTIONS WERE INITIATED. DESPITE THESE EFFORTS, RESUSCITATION WAS UNSUCCESSFUL, AND CLINICAL DEATH WAS DECLARED APPROXIMATELY 3 HOURS POST IMPLANTATION. THE CAUSE OF DEATH WAS SUSPECTED TO BE A REACTION TO THE BONE CEMENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 - FOREIGN: CHINA. 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

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A RETAIN SAMPLE OF THE CEMENT BATCH HAS BEEN TESTED IN THE LABORATORY UNDER STANDARDIZED CONDITIONS. NO UNUSUAL BONE CEMENT HEATING TEMPERATURE HAS BEEN NOTICED DURING POLYMERIZATION REACTION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS BATCH CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE REVIEW OF THE INSTRUCTION FOR USE (IFU) IDENTIFIED THE FOLLOWING SIDE EFFECT: 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. 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

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