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Fig. 1 Pinnacle Acetabular Shell (left) and Metal-On-Metal Liner (right)
Fig. 2 Pinnacle Acetabular Shell and Metal-On-Metal Liner, Assembled
In metal-on-metal hip implants the clearance between the head and liner interface is critical to
ensure that the bearing surfaces receive adequate lubrication for wear reduction. It is known
that in modern metal-on-metal hip implants a fluid film lubrication may occur where a thin
microscopic layer of lubricant completely separates the head and cup liner bearing surfaces
thus protecting the articulating surfaces during relative motion. By protecting these surfaces,
the fluid film lubrication plays a role in reducing the wear of metal-on-metal bearings. The
diametrical clearances for the subject liners with compatible femoral head are the same as
those for similar size components of the ASR system and the 36 mm Pinnacle metal liner
(See Table 1). Therefore, it is expected that the fluid film lubricant layer produced with the
subject liners will be the same as that for the previously cleared ASK Modular Acetabular
Cup System (K040627) and the 36mm Pinnacle metal liner (K003523) indicating the subject
liners will have similar wear rates. This has been confirmed through an in-vitro hip
:simulator wear test. The report for this study is provided in Exhibit VI.
0090015
PROTECTED DOCUMENT. DOCUMENT SUBJECT TO PROTECTIVE ORDER.
DEPUY022771644
Source: https://www.industrydocuments.ucsf.edu/docs/lpgn0226

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