Consumers and health professionals are advised that Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding OtisMed ShapeMatch Cutting Guides.
OtisMed ShapeMatch Cutting Guides are single-use instruments that can be used to assist in correct positioning of cuts that must be made to bones during knee replacement operations.
The guides are custom made for each patient using individual measurements taken prior to the operation.
It has been identified that some steps were not adequately described in the instrument's surgical instructions. Improper alignment of the implant components due to insufficient preparation of the bone before the cutting guides are used can lead to patients experiencing a range of problems, including joint instability, loss of mobility, and loss of motion or osteolysis. If these occur, the patient may require revision surgery.
No problems have been identified with the guides themselves and that the likelihood of patients experiencing the problems outlined above is low.
In a separate issue, Stryker Australia has identified a limited number of cases in which measurement values provided to surgeons via a web portal may have been inconsistent with the values used to manufacture the guides. It is important to note that all guides were made using the correct values, and that patients should not experience any additional problems as a result of this issue.
To rectify these issues, Stryker Australia has updated the surgical instructions and implemented an additional quality check to ensure the values displayed on the web portal are correct.
Information for consumers
Stryker Australia has written to surgeons who have used OtisMed ShapeMatch Cutting Guides, providing further information about the above issue.
OtisMed ShapeMatch Cutting Guides are not used in all knee replacement operations and, even if they have been used, the likelihood of patients experiencing the problems outlined above is low.
If you have had a knee replacement and experience joint instability, loss of mobility, loss of motion, unexpected swelling or any other unusual symptoms - or if you have any questions or concerns about the above issue - you should contact your surgeon or the hospital where the surgery was performed.
Information for all health professionals
If you are treating a patient who has had a knee replacement and is concerned about the above information, you should reassure them that OtisMed ShapeMatch Cutting Guides are not used in all knee replacement operations and, even if they have been used, the likelihood of patients experiencing the identified problems is low.
Patients who have had a knee replacement and are experiencing joint instability, loss of mobility, loss of motion, unexpected swelling or any other unusual symptoms should be referred to their surgeon or the hospital where the surgery was performed.
Information for orthopaedic surgeons
Patients who have received a total knee replacement in which OtisMed ShapeMatch Cutting Guides were used should be followed up according to their routine protocol and assessed for complications that could be associated with this issue. No additional patient follow-up or monitoring is required for these patients.
Investigations following customer complaints revealed the following issues:
- the surgical protocol for OtisMed ShapeMatch Cutting Guides did not provide sufficient information on:
- the position of the guides
- the need for osteophyte/soft tissue removal
- the need for proper axial drilling
- the need to avoid angulation and malalignment.
- the approved pre-operative plan did not provide sufficient information about the need for osteophyte removal
- the measurement values provided to surgeons via the OtisMed.net web portal may have been inconsistent with the values used to manufacture the guides. It is important to note that all guides were made using the values determined by the planning software based on MRI images, and that patients should not experience any problems as a result of this issue.
Stryker Australia has rectified these issues and any OtisMed ShapeMatch Cutting Guides supplied from now will include updated surgical instructions and an additional quality check will ensure the values displayed in the OtisMed.net portal are correct.
If you have any questions or concerns about this issue, contact your Stryker Australia representative.
Reporting problems
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.