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Zimmer Holdings Inc – ‘8-K’ for 3/11/10 – EX-99.1

On:  Friday, 3/12/10, at 6:00am ET   ·   For:  3/11/10   ·   Accession #:  950123-10-23796   ·   File #:  1-16407

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 3/12/10  Zimmer Holdings Inc               8-K:7,9     3/11/10    2:39K                                    RR Donnelley/FA

Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                      HTML     14K 
 2: EX-99.1     Miscellaneous Exhibit                               HTML     25K 


EX-99.1   —   Miscellaneous Exhibit


This exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]



  exv99w1  

Exhibit 99.1
Statement on the Zimmer NexGen® CR-Flex Porous Femoral Component
Zimmer’s 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, Zimmer’s 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 Zimmer’s 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 company’s 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.

 

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