These key surgical steps are highlights only and may not be used for training purposes. For the detailed procedure, please refer to the PINNACLE® Ceramic Liner Inserter Surgical Technique (DSEM/JRC/0716/0688(1))
PINNACLE® Ceramic Liner Inserter
The PINNACLE Ceramic Liner Inserter is designed to aid initial insertion of CERAMAX™ Liners in PINNACLE Acetabular Shell.
The Ceramic Liner Inserter consists of two radiolucent Radel® polyphenylsulfone (PPSU) components, a yellow “gripper” and a grey “pusher”. These components are not detectable by x-ray.
- Select the appropriate size “Pusher” and “Gripper” to match the internal and external diameters of the ceramic liner.
- Pusher size = inner diameter (Head size).
- Gripper size = outer diameter (Shell size).
- Orientate the Pusher and Gripper as shown.
- Align the Pusher with the central hole of the Gripper and firmly press together.
- Ensure that the Pusher arms are aligned with the gaps between the Gripper legs.
Assemble to Ceramic Liner
Place the subassembly on the ceramic liner with the gripper legs capturing the outer edge.
To ensure liner alignment and verify that all gripper legs are firmly fixed and flush to the liner, this may require significant effort to clip on.
Note: An audible click may be present during assembly.
Note: Ensure the liner is held firmly during assembly.
Note: Once assembled, the user should hold the inserter/liner construct either by the outer surfaces of the gripper legs or by the liner itself.
Position the Device
- Carefully advance the liner into the incision and align the face of the gripper to the face of the implanted acetabular cup.
- Care should be taken to avoid soft tissue or bony impingement.
- Ensure all three gripper legs are in contact with the face of the acetabular shell.
- Should any bony or soft tissue impingement occur during insertion of the ceramic liner inserter into the wound and seating on the shell, remove the ceramic liner inserter from the wound and modify the retractor positions to improve exposure.
- To determine if the ceramic liner inserter is flush with the face of the cup and there is no soft tissue impingement, visually inspect the area between the gripper legs and the shell.
- In addition the sub-assembly may be freely rotated on the face of the shell to ensure full contact between the gripper legs and the shell.,
Note: Lack of soft tissue and bony impingement may be confirmed by rotating the Liner Inserter freely on the Cup.
Manually deploy the ceramic liner inserter by firmly depressing the central button.
Note: No impaction should be used when deploying the device; Do not attempt to fully engage the taper locking mechanism by striking the Liner Inserter.
When the liner is released from the gripper and is “flush” with the face of the shell an audible cue should be apparent.
Note: If the liner has not been impacted by the impactor instrument, it is acceptable to remove the liner and repeat liner insertion. However, if the liner has been impacted by the impactor instrument and is unacceptably seated in the shell (e.g., canted), the liner should be removed and a new liner should be used.
- Carefully retrieve the device from the wound.
- Palpate the liner to confirm proper taper alignment and seating in the cup. The liner should sit flush relative to the face of the shell.
- If liner seating is acceptable, use an impactor with the appropriate size impactor tip for final seating of the CERAMAX Ceramic Insert. Final seating requires two to four moderate blows. If liner seating is not acceptable remove the liner and repeat liner insertion.