Attached files
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8-K - FORM 8-K - ZIMMER BIOMET HOLDINGS, INC. | c56948e8vk.htm |
Exhibit 99.1
Statement on the Zimmer NexGen® CR-Flex Porous Femoral Component
Zimmers NexGen® CR-Flex Porous Femoral component was the subject of a study of 108
patients (The High Failure Rate of a High-Flex Total Knee Arthroplasty Design) by
Drs. Berger and Della Valle of Rush University Medical Center. According to the
published abstract, Drs. Berger and Della Valle revised 9 (8.3%) patients for femoral
loosening and pain. The study also reported that 39 (36%) patients showed evidence of
radiographic loosening and that [l]oosening and revision were not related to surgeon,
approach or patient type.
The NexGen CR-Flex Porous component has a strong track record of clinical success.
According to the 2009 Australian National Joint Replacement Registry report, Zimmers
NexGen cementless total knee arthroplasty (TKA) components recorded the lowest
revision rate (reported as revisions per 100 observed component years) of all major
cementless TKA systems utilized in the market (0.5 revisions per 100 observed
component years). Of the 7,100 implantations using the NexGen CR Porous or NexGen
CR-Flex Porous systems since 2004, revisions were reported for 120 patients,
representing a revision rate of 1.7%, inclusive of all components and reasons for
revision.
The performance of the NexGen CR-Flex Porous Femoral component in the Australian
National Joint Registry and in Zimmers post-market surveillance activities
demonstrates that it is a safe and effective product when used as indicated in the
surgical technique. More than 150,000 NexGen CR and NexGen CR-Flex Porous Femoral
components have been sold since 2003. Sales of the NexGen CR-Flex Porous component
represented approximately 2% of the companys knee revenues in 2009.
2009 Australian National Joint Replacement Registry
Table
KT24: Revision Rates of Primary Total Knee Replacement with Cementless Fixation
Femoral | Tibial | N Revised | N Total | Obs. Years | Revisions per | Exact 95% Cl | |||||||||||||||||
Component | Component | 100 Obs. Yrs | |||||||||||||||||||||
Active Knee | Active Knee |
94 | 2864 | 9639 | 1.0 | (0.79, 1.19 | ) | ||||||||||||||||
Advance | Advance |
17 | 303 | 1415 | 1.2 | (0.70, 1.92 | ) | ||||||||||||||||
Advantim | Advantim |
8 | 666 | 2752 | 0.3 | (0.13, 0.57 | ) | ||||||||||||||||
Duracon | Duracon |
86 | 3249 | 12892 | 0.7 | (0.53, 0.82 | ) | ||||||||||||||||
Genesis II | Mobile Bearing Knee |
15 | 474 | 2641 | 0.6 | (0.32, 0.94 | ) | ||||||||||||||||
LCS | LCS |
111 | 2311 | 13802 | 0.8 | (0.66, 0.97 | ) | ||||||||||||||||
LCS | MBT |
305 | 12019 | 33869 | 0.9 | (0.80, 1.01 | ) | ||||||||||||||||
Maxim | Maxim |
20 | 577 | 3111 | 0.6 | (0.39, 0.99 | ) | ||||||||||||||||
Natural Knee II | Natural Knee |
45 | 899 | 4419 | 1.0 | (0.74, 1.36 | ) | ||||||||||||||||
Natural Knee II | Natural Knee II |
46 | 1509 | 5604 | 0.8 | (0.60, 1.09 | ) | ||||||||||||||||
Nexgen | Nexgen |
120 | 7100 | 23964 | 0.5 | (0.42, 0.60 | ) | ||||||||||||||||
Nexgen LPS | Nexgen |
7 | 323 | 509 | 1.4 | (0.55, 2.83 | ) | ||||||||||||||||
PFC Sigma | Coordinate |
22 | 1201 | 3910 | 0.6 | (0.35, 0.85 | ) | ||||||||||||||||
PFC Sigma | MBT |
59 | 1420 | 3987 | 1.5 | (1.13, 1.91 | ) | ||||||||||||||||
Profix | Profix |
32 | 1072 | 3801 | 0.8 | (0.58, 1.19 | ) | ||||||||||||||||
RBK | RBK |
65 | 2451 | 7330 | 0.9 | (0.68, 1.13 | ) | ||||||||||||||||
Rocc | Rocc |
6 | 333 | 497 | 1.2 | (0.44, 2.63 | ) | ||||||||||||||||
Rotaglide Plus | Rotaglide Plus |
14 | 362 | 1644 | 0.9 | (0.47, 1.43 | ) | ||||||||||||||||
Scorpio | Scorpio/Series 7000 |
129 | 4009 | 13178 | 1.0 | (0.82, 1.16 | ) | ||||||||||||||||
Triathlon | Triathlon |
16 | 1677 | 1680 | 1.0 | (0.54, 1.55 | ) | ||||||||||||||||
Other (47) | 209 | 2107 | 5702 | 3.7 | (3.19, 4.20 | ) | |||||||||||||||||
TOTAL | 1426 | 46926 | 156347 | 0.9 | (0.87, 0.96 | ) |
Note: Only prostheses with over 300 procedures have been listed. |