Table 4: Original Surgery Group and the Revision Surgery
Group Analyzed for Overall Revision, Infection (only)
Revision, and Mechanical Malfunction (only) Revision
Original Surgery
Group
Revision Surgery
Group
• Non-IZ devices
[% revision free]
771 (20.6%) [79.4%]
498 (26.3%) [73.7%]
Relative Risk Reduction**
[absolute reduction]
39.8%
[8.2%]
32.3%
[8.5%]
INFECTION (only) REVISION
Infection Free Patients
16,570 (98.6%)
6,083 (97.4%)
Infection Reported
Revisions
232 (1.4%)
160 (2.6%)
• IZ devices
[% revision free]
173 (1.3%) [98.7%]
100 (2.3%) [97.7%]
• Non-IZ devices
[% revision free]
59 (1.6%) [98.4%]
60 (3.2%) [96.8%]
Relative Risk Reduction**
[absolute reduction]
16.0%
[0.3%]
27.6%
[0.9%]
MECHANICAL MALFUNCTION (only) REVISION
Malfunction Free Patients
16,226 (96.6%)
5,945 (95.2%)
Malfunction Reported
Revisions
576 (3.4%)
298 (4.8%)
• IZ devices
[% revision free]
426 (3.3%) [96.7%]
183 (4.2%) [95.8%]
• Non-IZ devices
[% revision free]
150 (4.0%) [96.0%]
115 (6.1%) [93.9%]
Relative Risk Reduction**
[absolute reduction]
18.6%
[0.7%]
30.9%
[1.9%]
*Were removed from additional statistical analysis.
**Relative Risk Reduction (%) = [1 – (IZ event rate / Non-IZ event rate)] x 100
Original Surgery Group
Revisions Analyses OVERALL
The AMS 800 PIF reports included in the survival analyses
were from a total of 17,063 original implant surgeries,
including 13,060 (76.5%) IZ devices and 3,742 (21.9%)
Non-IZ devices. The remaining 261 (1.5%) implants, a mix
of IZ and Non-IZ components, were removed from additional
statistical analysis.
Revision free patients totaled 14, 410 (85.8%).
Only 2,392 revisions (14.2%) were recorded, of which 1,621
(12.4%) revisions were in the IZ group (i.e., 87. 6% revision
free rate), while 771 (20.6%) revisions were in the Non-IZ
treated group (i.e., 79.4% revision free rate). The IZ group
demonstrated an 39.8% relative risk reduction of overall
revision compared to the Non-IZ group.
Revision Due to INFECTION
Infection free patients totaled 16,570 (98.6%).
Only 232 infection related events (1.4%) were recorded, i.e.,
173 (1.3%) infection related events with IZ devices (infection
free rate 98.7%) and 59 (1.6%) infection related events in
the Non-IZ group (infection free rate 98.4%). The IZ group
demonstrated a 16.0% relative risk reduction of infection
compared to the Non-IZ group.
Revisions Due to MECHANICAL MALFUNCTION
Malfunction free patients totaled 16,226 (96.6%).
Only 576 reported mechanical malfunction events (3.4%)
occurred. A total of 426 (3.3%) devices experienced
mechanical malfunction in the IZ group (malfunction free rate
12
