BIOMET BONE CMENT R 1X40 JP

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2A, G3, G6, H2, H6, H11. A FAT EMBOLISM (FE) IS A PIECE OF INTRAVASCULAR FAT THAT LODGES WITHIN A BLOOD VESSEL AND CAUSES A BLOCKAGE OF BLOOD FLOW. FAT EMBOLI COMMONLY OCCUR AFTER FRACTURES IN THE LONG BONES OF THE LOWER BODY, PARTICULARLY THE FEMUR (THIGHBONE), TIBIA (SHINBONE), AND PELVIS. THEY CAN ALSO OCCUR POST OPERATIVELY AFTER CERTAIN ORTHOPEDIC SURGERIES. IT'S NOT EXACTLY KNOWN HOW FAT EMBOLI AND SUBSEQUENT FAT EMBOLISM SYNDROME (FES) OCCUR, BUT ONE LEADING GUESS IS THE MECHANICAL OBSTRUCTION THEORY. THE IDEA BEHIND THIS THEORY IS THAT WHEN LARGE BONES BREAK, FAT FROM THE BONE MARROW, WHICH IS MADE UP OF FATTY CELLS, SEEPS INTO THE BLOODSTREAM. THIS FAT CREATES CLOTS (FAT EMBOLI) THAT OBSTRUCT BLOOD FLOW OFTEN IN THE LUNGS. THESE EMBOLI ALSO PRODUCE WIDESPREAD INFLAMMATION. ANOTHER THEORY CALLED THE CHEMICAL THEORY. IT'S THOUGHT THAT THE BODY RESPONDS TO THE FAT EMBOLI BY SECRETING CHEMICALS WHICH CAUSE THE FORMATION OF FREE FATTY ACIDS, GLYCEROL, AND OTHER SUBSTANCES WHICH, IN TURN, DAMAGE CELLS AND ORGANS. CERTAIN PEOPLE ARE KNOWN TO BE AT HIGHER RISK INCLUDING BEING MALE, BEING BETWEEN THE AGES OF 20 AND 30, HAVING A CLOSED FRACTURE (THE BROKEN BONE DOESN'T PENETRATE THE SKIN), HAVING MULTIPLE FRACTURES, ESPECIALLY IN THE LOWER EXTREMITIES AND PELVIS. THERE IS NO TEST THAT DIAGNOSES A FAT EMBOLISM OR FAT EMBOLISM SYNDROME. GURD'S CRITERIA ARE USED TO DIAGNOSE. THERE IS NO DEFINITIVE TREATMENT FOR FAT EMBOLISM SYNDROME. TREATMENT IS AIMED AT SUPPORTIVE CARE. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THIS IS A LIMITED INVESTIGATION; A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW WILL NOT BE COMPLETED FOR LIMITED INVESTIGATION COMPLAINTS AS THE PRODUCT MEETS THE APPLICABLE ACCEPTANCE CRITERIA. ROOT CAUSE HAS BEEN IDENTIFIED AS THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED 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.

Description of Event or Problem

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

Description of Event or Problem

IT WAS REPORTED THAT THE DURING CEMENTING WITH BBC-PACK AND OPTIVACK L (INJECTED 3.5 MIN AFTER MIXING; STEM INSERTED AT 5.5 MIN), THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND SIGNS OF PULMONARY EMBOLISM, LIKELY DUE TO EXCESSIVE PRESSURE DISLODGING THE CEMENT PLUG AND CAUSING DISTAL FAT EMBOLISM. THE PATIENT REGAINED CONSCIOUSNESS THE NEXT DAY AND WAS TRANSFERRED FROM ICU TO THE GENERAL WARD, WITH NO CONFIRMED CEMENT ALLERGY. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: ITEM NAME# BIOMET BONE CMENT R 1X40 JP; ITEM NUMBER# 110035372; LOT NUMBER# V28AAA0213. ITEM NAME# BIOMET BONE CMENT R 1X40 JP; ITEM NUMBER# 110035372; LOT NUMBER# V28AAC0811. ITEM NAME# CMK REVSTM CM MD12/14 201 L200; ITEM NUMBER# 3553.291-200; LOT NUMBER# 0001796088. ITEM NAME# DELTA CER FM HD 036/-4MM 12/14; ITEM NUMBER# 650-0836; LOT NUMBER# 3231287. ITEM NAME# CABLE READY GTR COCR CABLE; ITEM NUMBER# 00-2232-004-18; LOT NUMBER# 64236877. ITEM NAME# CABLE READY GTR COCR CABLE; ITEM NUMBER# 00-2232-004-18; LOT NUMBER# 64438842. ITEM NAME# CABLE READY GTR COCR CABLE; ITEM NUMBER# 00-2232-004-18; LOT NUMBER# 64492646. 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 K172408. 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.