Table 5 Incidence of SAE’s according to EC-GCP-guidelines

Death

2

2

Bleeding-related SAE

Wound hematoma

2

5

Wound hematoma infection

-

-

Wound infection

-

-

Bleeding events

3

9

Non-Bleeding-related SAE

Chest pain

1

1

Myocardial infarction

1

2

AV-Block

0

1

Pulmonary embolism

0

1

Staphylococcus aureus infection

3

0

Metastatic carcinoma

-

-

Coxarthrosis

-

-

Prostata-adenoma

-

-

Retention of urine

-

-

Implant dislocation

2

3

Implant change

0

1

Second hip surgery

3

0

Further fracture

0

1

Any other re-operation

0

1