Table 2 Adverse events

Death

 90 days

0/2416 (0.00%)

0/1250 (0.00%)

0/909 (0.00%)

0/257 (0.00%)

 365 days

 < 11/2416 (< 0.5%)

 < 11/1250 (< 0.9%)

0/909 (0.00%)

0/257 (0.00%)

All cause medical complications

 90 days

348/2416 (14.40%)

174/1250 (13.90%)

130/909 (14.30%)

44/257 (17.10%)

 365 days

583/2416 (24.10%)

297/1250 (23.80%)

203/909 (22.30%)

83/257 (32.30%)

Thromboembolic disease

 90 days

 > 43/2416 (> 1.8%)

23/1250 (1.8%)

17/909 (1.9%)

 < 11/257 (< 4.28%)

 365 days

 > 74/2416 (> 3.0%)

38/1250 (3.0%)

28/909 (3.1%)

 < 11/257 (< 4.28%)

Osteolysis

 90 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

 365 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

Myocardial infarction

 90 days

 < 33/2416 (< 1.4%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

 365 days

 > 30/2416 (> 1.2%)

14/1250 (1.1%)

15/909 (1.7%)

 < 11/257 (< 4.28%)

Heart failure

 90 days

119/2416 (4.9%)

56/1250 (4.5%)

51/909 (5.6%)

12/257 (4.7%)

 365 days

171/2416 (7.1%)

75/1250 (6.0%)

68/909 (7.5%)

28/257 (10.9%)

Respiratory failure

 90 days

32/2416 (1.3%)

13/1250 (1.0%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

 365 days

66/2416 (2.7%)

33/1250 (2.6%)

20/909 (2.2%)

13/257 (5.1%)

Stroke

 90 days

 > 30/2416 (> 1.2%)

12/1250 (1.0%)

13/909 (1.4%)

 < 11/257 (< 4.28%)

 365 days

84/2416 (3.5%)

43/1250 (3.4%)

26/909 (2.9%)

15/257 (5.8%)

Acute renal function

 90 days

 > 41/2416 (> 1.7%)

27/1250 (2.2%)

12/909 (1.3%)

 < 11/257 (< 4.28%)

 365 days

110/2416 (4.6%)

60/1250 (4.8%)

36/909 (4.0%)

14/257 (5.4%)

Urinary tract infection

 90 days

145/2416 (6.0%)

75/1250 (6.0%)

53/909 (5.8%)

17/257 (6.6%)

 365 days

287/2416 (11.9%)

150/1250 (12.0%)

103/909 (11.3%)

34/257 (13.2%)

All cause surgical complications

 90 days

480/2416 (19.9%)

307/1250 (24.6%)

87/909 (9.6%)

86/257 (33.5%)

 365 days

513/2416 (21.2%)

323/1250 (25.8%)

100/909 (11.0%)

90/257 (35.0%)

Wound complications

 90 days

 < 22/2416 (< 0.9%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

0/257 (0.0%)

 365 days

 < 22/2416 (< 0.9%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

0/257 (0.0%)

Bleeding

 90 days

 < 22/2416 (< 0.9%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

0/257 (0.0%)

 365 days

 < 22/2416 (< 0.9%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

0/257 (0.0%)

Neural deficit

 90 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

 365 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

Vascular injury

 90 days

 < 11/2416 (< 0.5%)

 < 11/1250 (< 0.9%)

0/909 (0.0%)

0/257 (0.0%)

 365 days

 < 11/2416 (< 0.5%)

 < 11/1250 (< 0.9%)

0/909 (0.0%)

0/257 (0.0%)

Instability

 90 days

 < 11/2416 (< 0.5%)

0/1250 (0.0%)

 < 11/909 (< 1.2%)

0/257 (0.0%)

 365 days

 < 33/2416 (< 1.4%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

Stiffness

 90 days

436/2416 (18.0%)

292/1250 (23.4%)

60/909 (6.6%)

84/257 (32.7%)

 365 days

464/2416 (19.2%)

305/1250 (24.4%)

72/909 (7.9%)

87/257 (33.9%)

Periprosthetic fracture

 90 days

 < 22/2416 (< 0.9%)

0/1250 (0.0%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

 365 days

 < 33/2416 (< 1.4%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

Extensor mechanism disruption

 90 days

 < 11/2416 (< 0.5%)

 < 11/1250 (< 0.9%)

0/909 (0.0%)

0/257 (0.0%)

 365 days

 < 11/2416 (< 0.5%)

 < 11/1250 (< 0.9%)

0/909 (0.0%)

0/257 (0.0%)

Bearing surface wear

 90 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

 365 days

0/2416 (0.0%)

0/1250 (0.0%)

0/909 (0.0%)

0/257 (0.0%)

Implant loosening

 90 days

 < 22/2416 (< 0.9%)

0/1250 (0.0%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

 365 days

 < 33/2416 (< 1.4%)

 < 11/1250 (< 0.9%)

 < 11/909 (< 1.2%)

 < 11/257 (< 4.28%)

Deep periprosthetic joint infection

 90 days

 > 20/2416 (> 0.8%)

 < 11/1250 (< 0.9%)

13/909 (1.4%)

0/257 (0.0%)

 365 days

 > 25/2416 (> 1.0%)

12/1250 (1.0%)

14/909 (1.5%)

 < 11/257 (< 4.28%)