Consumers and health professionals are advised that Zimmer, in consultation with the TGA, is issuing a hazard alert regarding some lots of its Trilogy bone screws due to their potential to fracture. Zimmer is also undertaking a recall of unused screws from affected lots.
Trilogy bone screws are used to secure the acetabular component to the pelvis during total hip replacement procedures.
Machining marks left behind on some of the screws leave them prone to fatigue fractures. This issue only affects some lots of 6.5 mm x 35 mm and 6.5 mm x 25 mm Trilogy bone screws.
If a screw fractures during surgery it could lead to difficulty in securing an implant and the potential for bone damage during screw removal. Failure of the Trilogy bone screws once implanted could result in the need for corrective surgery.
The affected lot numbers are:
Information for consumers
Zimmer has contacted surgeons and the hospitals where the affected Trilogy bone screws have been used to notify them of this problem and provide advice on the appropriate patient follow-up. It should be noted that this issue is caused by force applied when turning the screws during surgery and is unlikely to occur once in place.
If you, or someone you care for, are experiencing issues such as pain, discomfort or unexpectedly restricted movement you should seek advice promptly from your treating health professional. If no problems are experienced, you should maintain any pre-arranged follow-up program with your treating health professional.
Information for all health professionals
Patients who have had a Trilogy hip implant and who have any questions or concerns about the above issue should be referred to their surgeon or to the hospital where the surgery was undertaken.
Information for orthopaedic surgeons and hospitals
Zimmer has contacted surgeons and the hospitals where the affected Trilogy bone screws have been used to notify them of this problem and provide advice on the appropriate patient follow-up.
Zimmer advises that a screw fracturing in an existing implant could require revision surgery, although this is unlikely to occur as the issue is caused by torsional forces which are not present post-operatively.
Surgeons and hospitals should check any unused Trilogy bone screws they have in stock to see if any are affected by this recall. If they are, those screws should not be used. Instead, they should be quarantined before being returned to Zimmer. Telephone Zimmer on (02) 9483 5400 or email firstname.lastname@example.org to arrange return.
Patients who have already had procedures in which 6.5 mm x 35 mm and 6.5 mm x 25 mm Trilogy bone screws were used should be followed up in accordance with routine protocols and assessed for any signs or symptoms that may be related to this issue.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.