REFOBACIN BONE CEMENT R 1X40-3

Additional Manufacturer Narrative

(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2: FOREIGN - EVENT OCCURRED IN FRANCE. G-4: 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY AFTER FALLING OUT OF HER HOSPITAL BED AT HOME, EXPERIENCING PAIN IN THE RIGHT HIP, FUNCTIONAL IMPAIRMENT, AND IMAGING STUDIES CONFIRMED A FEMORAL NECK FRACTURE. DURING THE SURGICAL PROCEDURE, THE PATIENT REMAINED STABLE BOTH HEMODYNAMICALLY AND RESPIRATORY. CEMENTATION OF THE PROSTHESIS WAS PERFORMED WITHOUT COMPLICATIONS. AT THE END OF THE PROCEDURE DURING SKIN CLOSURE, THE PATIENT EXPERIENCED A SUDDEN HEMODYNAMIC COLLAPSE, ACCOMPANIED BY EXTREME BRADYCARDIA. THE PATIENT RAPIDLY PROGRESSED TO CARDIORESPIRATORY ARREST WITH ELECTROMECHANICAL DISSOCIATION. EXTERNAL CARDIAC MASSAGE WAS IMMEDIATELY INITIATED WITH OROTRACHEAL INTUBATION TO OPTIMIZE VENTILATION. IN TOTAL, AFTER 10 MINUTES OF CARDIOPULMONARY RESUSCITATION AND THE ADMINISTRATION OF EPINEPHRINE, A TRANSITION TO VENTRICULAR TACHYCARDIA WAS OBSERVED. AFTER DELIVERING TWO EXTERNAL ELECTRICAL SHOCKS THE MEDICAL TEAM RESTORED A SPONTANEOUS HEART RHYTHM WITH SATISFACTORY SPONTANEOUS VENTILATION. ON CLINICAL EXAMINATION, HOWEVER, ANISOCORIA WITH UNRESPONSIVE RIGHT-SIDED MYDRIASIS WAS NOTED. THE PATIENT WAS THEN TRANSFERRED TO THE POST-ACUTE CARE UNIT ON MECHANICAL VENTILATION AND VASOPRESSOR SUPPORT, BLOOD TESTING, AND MONITORING FOR A POSSIBLE RETURN TO CONSCIOUSNESS. UPON ARRIVAL AT THE EMERGENCY DEPARTMENT, THE PATIENT PRESENTED WITH A NEW ACUTE RESPIRATORY FAILURE. GIVEN THE PATIENT'S MEDICAL HISTORY, A CONSENSUS DECISION WAS REACHED NOT TO ATTEMPT FURTHER CARDIOPULMONARY RESUSCITATION. THE PATIENT LATER PASSED AWAY DUE TO A POSSIBLE CEMENT EMBOLISM COMPLICATED BY CARDIOGENIC SHOCK PROGRESSING TO CARDIORESPIRATORY ARREST. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

Description of Event or Problem

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

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. THE FOLLOWING SECTION WAS CORRECTED: H6 - COMPONENT CODE.NO PRODUCT WAS RETURNED OR PICTURES PROVIDED A PRODUCT EVALUATION COULD NOT BE PERFORMED. HOWEVER, A SAMPLE RETAINED BY THE MANUFACTURER FROM THE SAME BATCH WAS TESTED TO CONFIRM THAT THE CEMENT CURES WITHIN AN ACCEPTABLE TIME AND WITHOUT EXCEEDING THE ALLOWABLE PEAK EXOTHERMIC TEMPERATURE UNDER ISO 5833 CONDITIONS. THE SAMPLE WAS FOUND TO CONFORM TO THE APPLICABLE SPECIFICATIONS.A REVIEW OF THE DEVICE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ABNORMALITIES OR DEVIATIONS RELATED TO THE REPORTED INCIDENT.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.THE CASE WAS REVIEWED WITH A HEALTH CARE PROFESSIONAL. IT WAS IDENTIFIED THAT THE PATIENT WAS AN 80-YEAR-OLD FEMALE WITH A FEMORAL NECK FRACTURE AND SIGNIFICANT COMORBIDITIESINCLUDING: COPD REQUIRING LONG-TERM HOME OXYGEN THERAPY, HYPERTENSION, AND A PRIOR STROKE. OF NOTE, THE FEMORAL NECK FRACTURE OCCURRED ON (b)(6) 2026, AND SURGERY OCCURRED 48 HOURS LATER. THESECOMORBIDITIES, TOGETHER WITH REDUCED FUNCTIONAL STATUS AND LIMITED MOBILITY FOR 2 DAYS, MAY HAVE INCREASED THE PATIENT¿S RISK TO INTRAOPERATIVE CARDIOPULMONARY COMPLICATIONS.BASED ON THE INFORMATION AVAILABLE TO DATE, THE REPORTED ADVERSE EVENT IS CONSIDERED CONSISTENT WITH BONE CEMENT IMPLANTATION SYNDROME (BCIS), WHICH IS A KNOWN INHERENT RISK WITH THE USE OF BONECEMENT PRODUCTS AS LISTED IN THE INSTRUCTIONS FOR USE ((IFU) 9878300010 REV. 05). BCIS IS GENERALLY UNDERSTOOD TO BE MULTIFACTORIAL IN ORIGIN AND IS COMMONLY ASSOCIATED WITH THE INFILTRATION OF EMBOLI INTO THE VASCULAR SYSTEM. SUCH EMBOLIC MATERIAL MAY INCLUDE, BUT ARE NOT LIMITED TO, FAT, BONE MARROW, BONE DEBRIS, OR GAS. THE OCCURRENCE OF BCIS MAY BE INFLUENCED BY MULTIPLE PROCEDURAL AND PATIENT-RELATED FACTORS. THE ROOT CAUSE THEREFORE OF THE REPORTED ISSUE IS NOT CONSIDERED TO BE RELATED TO THE DEVICE.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.