Study: NCT04012567

Adverse event: Prepuce balanitis, prepuce too long
Serious: yes
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Left knee anterior cruciate ligament rupture,lateral meniscus root tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Foreign body reaction
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Thrombosis:middle & lower left superficial femoral, popliteal, posterior tibial,& intermuscular vein
Serious: yes
Organ System: Vascular disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: INJURY OF POSTERIOR HORN OF MENISCUS ON THE LEFT KNEE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Wound complication
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 4 affected / 69 at risk

Adverse event: FLAT WART
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SYMPTOMS OF LOW GRADE FEVER
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Renal and urinary disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: LIGAMENT STRAIN IN LEFT KNEE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Reproductive system and breast disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: POSTOPERATIVE ANESTHESIA GASTROINTESTINAL REACTION
Serious: no
Organ System: Gastrointestinal disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: POSSIBLE HYPOGLYCAEMIA
Serious: no
Organ System: Endocrine disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: FREQUENT URINATION
Serious: no
Organ System: Renal and urinary disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SOFT TISSUE STRAINS OF RIGHT FOOT
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SWELLING IN THE LEFT KNEE
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: QUADRICEPS ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: LEFT QUADRICEPS ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: SLIGHT SWELLING OF THE LEFT KNEE JOINT
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: SYMPTOMS OF FEVER
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: SOFT TISSUE CONTUSION OF LEFT KNEE
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: TENOSYNOVITIS STENOSANS OF STYLOID PROCESS OF RADIUS OF LEFT WRIST
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: FALL INDUCED PAIN IN RIGHT KNEE JOINT FOR 3 DAYS
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: NUMBNESS IN THE MEDIAL LEG
Serious: no
Organ System: Nervous system disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: ANTERIOR TISSUE SWELLING OF RIGHT KNEE
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: PAIN IN THE RIGHT KNEE JOINT CAUSED BY SPRAIN
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: BONE MARROW TUNNEL CYST OF THE RIGHT KNEE TIBIA
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: ECZEMATOID DERMATITIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: POSTOPERATIVE DYSFUNCTION OF LEFT KNEE JOINT TRAUMA
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: PAIN IN THE WOUND
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: ATROPHY OF THE QUADRICEPS FEMORIS OF THE LEFT LOWER EXTREMITY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Foreign body reaction
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: THROMBOSIS OF RIGHT LOWER EXTREMITY
Serious: no
Organ System: Vascular disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 2 affected / 69 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SWELLING OF SOFT TISSUE AROUND THE LEFT KNEE
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Scrotal inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: LEFT KNEE CONTUSION
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SKIN PAPILLOMA（ FLAT WARTS)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Prostatitis
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Thyroid mass
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: SECONDARY OLIGOMENORRHEA
Serious: no
Organ System: Reproductive system and breast disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 69 at risk

Adverse event: MAMMARY PAIN
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: RIGHT QUADRICEPS ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 69 at risk

Adverse event: Meniscus Injury of the right knee
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Pharyngeal disorder
Serious: yes
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Anterior cruciate ligament injury in right knee, meniscus injury in right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: PERIFOLLICULAR KERATOSIS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Wound complication
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 6 affected / 70 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Endocrine disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: ACROMIAL IMPINGEMENT SYNDROME
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: SWELLING OF LEFT KNEE
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT PLANTAR FASCIITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: UPPER RESPIRATORY INFECTION (URI)
Serious: no
Organ System: Infections and infestations
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: LEFT PLANTAR FASCIITIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: QUADRICEPS ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 3 affected / 70 at risk

Adverse event: Laryngopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT KNEE OSTEOARTHRITIS AGGRAVATED
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: definitely not related to device
Frequency: 2 affected / 70 at risk

Adverse event: CONJUNCTIVITIS OF THE RIGHT EYE
Serious: no
Organ System: Eye disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: INCISION REDNESS AND SWELLING
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: SYNOVITIS OF THE RIGHT KNEE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: FOCAL NODULAR HYPERPLASIA OF LIVER
Serious: no
Organ System: Hepatobiliary disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: DISUSE OSTEOPOROSIS OF THE RIGHT KNEE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 2 affected / 70 at risk

Adverse event: RIGHT QUADRICEPS FEMORIS MUSCLE ATROPHY
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: SWELLING IN THE RIGHT KNEE
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: FEVER SYMPTOM
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Traumatic arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: Inflammation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: PALPITATE
Serious: no
Organ System: Cardiac disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: HYPERLIPIDEMIA WITH ATHEROSCLEROSIS
Serious: no
Organ System: Vascular disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: DISUSE OSTEOPOROSIS OF THE LEFT KNEE
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT KNEE PAIN
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT KNEE EFFUSION
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: SWELLING IN THE RIGHT LOWER EXTREMITY
Serious: no
Organ System: General disorders
Notes: possibly related to the device
Frequency: 2 affected / 70 at risk

Adverse event: OOR MOTION OF THE RIGHT KNEE JOINT (LACK OF EXERCISE AFTER SURGERY)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: QUADRICEPS ATROPHY OF THE RIGHT LOWER LIMB
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: possibly related to the device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT RADIAL STYLOIDITIS
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: CHRONIC VAGINITIS
Serious: no
Organ System: Infections and infestations
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: POSTOPERATIVE JOINT HEMATOMA
Serious: no
Organ System: Vascular disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: ANTERIOR TISSUE SWELLING OF RIGHT KNEE
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: KNEE PAIN IN RIGHT KNEE
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: RIGHT KNEE PAIN
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Animal scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: URINE OCCULT BLOOD
Serious: no
Organ System: Renal and urinary disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk

Adverse event: CONJUNCTIVITIS OF BOTH EYES
Serious: no
Organ System: Eye disorders
Notes: definitely not related to device
Frequency: 1 affected / 70 at risk