Study: NCT04255394

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death (any cause, not related to procedure/implant)
Frequency: 36 affected / 208 at risk

Adverse event: Device Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: Revision surgery with removal of the study device (any component of the hip)
Frequency: 15 affected / 208 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: First and recurrent dislocations
Frequency: 4 affected / 208 at risk

Adverse event: Fracture of femur or acetabulum
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 208 at risk

Adverse event: Greater trochanteric pain syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Initial cup instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 208 at risk

Adverse event: Pain - Intermittent
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Deep vein Trombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The initial CRF in the study did not allow to mark an event as serious yes/no. Therefore, all reported events are recorded as an SAE.
Frequency: 1 affected / 208 at risk

Adverse event: Fall on shoulder without injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death (any cause, not related to procedure/implant)
Frequency: 26 affected / 449 at risk

Adverse event: Device Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: Revision surgery with removal of the study device (any component of the hip)
Frequency: 10 affected / 449 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: First and recurrent dislocations
Frequency: 9 affected / 449 at risk

Adverse event: Fracture of femur or acetabulum
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 449 at risk

Adverse event: Greater trochanteric pain syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 449 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 449 at risk

Adverse event: Total Hip replacement contralateral
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 449 at risk

Adverse event: Initial cup instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 449 at risk

Adverse event: Noise from the hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 449 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 449 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 449 at risk

Adverse event: Facet joint
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 449 at risk

Adverse event: Pain syndrom
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 449 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 449 at risk

Adverse event: Severe hip pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Sciatic Nerve Encace
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 449 at risk

Adverse event: Swelling finger
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 449 at risk

Adverse event: Femoral subsidence
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: BILAT BK AMPUTATIONS
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 449 at risk

Adverse event: Ankle replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 449 at risk

Adverse event: Calcar Crack
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Injury after fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 449 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Sponteneous bleeds
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Trochanteric Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Thigh Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: vertrebral collapse
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Terminally Ill
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Musculoskeletal discomfort
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: PSOAS Strain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain in left lateral thigh after fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: RIGHT CARPAL TUNNEL DECOMPRESSION
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 449 at risk