REFOBACIN BC R 1X40 US

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. REVIEW OF THE REPORTED EVENT BY A HEALTH CARE PROFESSIONAL FOUND: --PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. --THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE DEVICE. --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. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS (BLOOD CLOT), OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVELY TO PREVENT DVT FORMATION. DESPITE PROPHYLAXIS, DVTS CAN STILL DEVELOP WHICH CAN THEN BREAK FREE WITHIN THE VESSEL AND OCCLUDE OR BLOCK THE BLOOD FLOW IN THE LUNGS, KNOWN AS A PULMONARY EMBOLISM (PE). AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBIDITIES, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS (BLOOD CLOT), OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. TOTAL JOINT PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVELY TO PREVENT DVT FORMATION. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION, DVTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED, A POST-OPERATIVE COMPLICATION OCCURRED, AND MEDICAL INTERVENTION WAS REQUIRED FOR TREATMENT.

Description of Event or Problem

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

Additional Manufacturer Narrative

(B)(4). D10 - ASSOCIATED MEDICAL DEVICES: CRUCIATE RETAINING LEFT SIZE 10 PPS STANDARD FEMUR; ITEM# 42508606801; LOT# 66485221. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE G; ITEM# 42532007901; LOT# 67018374. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM; ITEM# 42512100912; LOT# 65552293. 38MM DIAMETER 10.0MM THICKNESS OSSEOTI POROUS 3-PEG PATELLA; ITEM# 42540500038; LOT# 66737902. UNKNOWN PATELLA ORIF; ITEM# UNKNOWN; LOT# UNKNOWN. 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 A STUDY PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TWENTY-FOUR DAYS POST-OP, WAS HOSPITALIZED WITH A DIAGNOSIS OF A URINARY TRACT INFECTION, DEEP VEIN THROMBOSIS, AND PULMONARY EMBOLISM. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND ANTICOAGULATION. THE EVENT IS ONGOING BUT IMPROVING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.