6
EN
Adverse effects:
All joint prostheses are subject to wear. JRI Ltd recommends the use of specific
materials to minimise wear, i.e. ceramic femoral heads. JRI Ltd can take no responsibility for the
effects of wear debris, dislocations, subluxation, rotation problems, decreased range of motion,
lengthening/shortening of the leg or from erroneous indication, incorrect operative technique,
or inadequate aseptic precautions. A decreased range of motion may be caused through
improper positioning or looseness of components. Loosening may also occur due to inadequate
fixation or improper positioning. Bone fractures may result from one-sided overloading or
weakening of the bone substance. Early or late infection may require the removal of the implant.
Allergic reactions to the implant materials can sometimes occur.
Revision:
In general for revision a larger stem and acetabular cup must be used. A longer
distal length is provided for additional stability. Proximal stability is advised for all stems where
applicable. Distal fixation should be used with caution (see intra-operative note). When ceramic
femoral heads are to be replaced a range of Revision Ceramic heads are available otherwise a
metal femoral head MUST be used with a PE cup liner. For revision operations the notes in this
Instruction For Use apply. Ensure that all fragments of the primary prosthesis and any bone
cement (if applicable) are removed, the area cleansed and prepared in accordance with the
operative technique instructions.
Storage & Handling:
Components of the Securus and Furlong® H-A.C. Revision stem ranges
are supplied sterile having been sterilised by Gamma irradiation. The components should be
stored in their original boxes in a clean and dry atmosphere, protected from direct sunlight. If
the inner packaging becomes wet, is damaged or is opened, do not use. JRI do not recommend
the resterilisation of medical devices. Do not use this product after the expiry date (year-month)
shown on the product packaging. Exposed articular surfaces must be neither marked nor come
into contact with metallic or hard objects. Touching the articular surfaces, the Hydroxy-apatite
coating or the spigot taper on the stem must be avoided. If they are damaged in any way the
device should not be implanted, but returned to JRI Orthopaedics Ltd for inspection. A femoral
head should be fitted immediately after removing the protective cap on the stem taper. Joint
prostheses must be neither treated mechanically nor modified. Visibly damaged, scratched,
improperly handled implants and implants that have already been used must not be implanted
under any circumstances as the functionality, integrity and/or sterility of that device may have
been adversely affected and therefore cannot be guaranteed.
155-030 (issue 6).indd 6
7/5/2012 6:15:50 PM
Superceded