PALACOS® R+G pro

Additional Manufacturer Narrative

CAUSAL ANALYSIS: SINCE HIGHER TRYPTASE LEVELS ARE INDICATING MAST CELL ACTIVATION, MOST LIKELY THE REPORTED CARDIOVASCULAR COLLAPSE IS RELATED TO AN ALLERGIC REACTION / ANAPHYLACTIC SHOCK. AN ALLERGY TEST WAS ALSO REQUESTED BY THE HOSPITAL, HOWEVER, UP UNTIL NOW WE HAVE NOT RECEIVED THE RESULTS. THUS, CURRENTLY IT IS NOT ASSESSABLE WHETHER THE PATIENT HAD AN ALLERGIC REACTION TO OUR BONE CEMENT OR TO OTHER MEDICATION DURING THE SURGERY. PROBABLE TRIGGER FOR HYPERSENSITIVITY REACTIONS TO THE BONE CEMENT ARE THE FOLLOWING COMPONENTS: BENZOYL PEROXIDE (BPO), N,N-DIMETHYL-P-TOLUIDINE (DMPT), HYDROQUINONE, ANTIBIOTICS (E.G. GENTAMICIN). AN ALLERGIC REACTION TO BONE CEMENTS COMPONENTS IS A KNOWN SIDE-EFFECT THAT IS ALSO STATED IN THE INSTRUCTIONS FOR USE OF THE DEVICE AND WOULD NOT BE RELATED TO A MALFUNCTION.

Description of Event or Problem

IT WAS REPORTED THAT A 71 YEARS-OLD, MALE PATIENT UNDERWENT CEMENTED SHOULDER ARTHROPLASTY DUE TO OSTEOARTHRITIS. DURING SUTURING (10 MINUTES AFTER CEMENTATION) THE PATIENT DEVELOPED A SEVERE CARDIOVASCULAR COLLAPSE. THE PATIENT WAS UNRESPONSIVE TO HIGH DOSES OF VASOACTIVE MEDICATION AND REQUIRED CARDIOPULMONARY RESUSCITATION. CIRCULATORY INSTABILITY FOLLOWING ROSC ACHIEVED AFTER 1 MINUTE OF CHEST COMPRESSIONS. ALL INVESTIGATIONS, INCLUDING CT SCANS, WERE NORMAL EXCEPT FOR TRYPTASE, WHICH WAS SLIGHTLY ELEVATED. THE PATIENT WAS TRANSFERRED TO ICU AND WAS ABLE TO RECOVER WITHOUT SERIOUS INJURY AND HAS BEEN DISCHARGED FROM HOSPITAL. PATIENT: MALE, 71Y/O; 96KG; 194CM MEDICAL HISTORY: HYPERTENSION, ATRIAL FIBRILLATION (ABLATATION PERFORMED IN APRIL). HYPERLIPIDAEMIA, DIABETES, ANXIETY. NO ALLERGIES CONCOMITANT MEDICATION: ELIQUIS, METFORMIN, ROSUVASTATIN, TARGINIQ, LANTUS, OZEMPIC. INDICATION FOR SURGERY: SHOULDER OSTEOARTHRITIS - SHOULDER REPLACEMENT OPERATION DATE: (B)(6) 2026 DURATION OF OPERATION: 3H. MEDICATION DURING SURGERY: PROPOFOL, REMIFENTANIL, NORADRENALINE, EPHEDRINE, TRANEXAMIC ACID, CLOXACILLIN, BENZYLPENICILLIN, MIDAZOLAM, PARACETAMOL, ONDANSETRON, BETAMETHASONE, ROCURONIUM, LIDOCAINE, ROPIVACAINE, ADRENALINE, RINGER'S ACETATE, SODIUM CHLORIDE. IMPLANTS: 1.6S SINGLE PIN, AR-UNIVERS II APEX SHORT SHAFT, AR-UNIVERS II HUMERAL HEAD, AR PIN 2.8X300MM , AR-9207FIBERWIRE , AR 72171.6S DOUBLE PIN, AR-UNIVERS II ECLIPSE GLENOID.