Lima Orthopaedics Australia Pty Ltd is alerting patients who had anatomic shoulder arthroplasty procedures, and specifically have been implanted SMR MB L1 Liner within the SMR/SMR L1 total stemmed devices.
What is the problem?
Specific to the product codes below, anatomic shoulder arthroplasty procedures containing the SMR MB L1 Liner have been identified in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) as having a higher-than-anticipated revision rate when compared to a group of similar devices.
| Product Code | Description | GTIN |
|---|---|---|
| 1377.50.005 | SMR Metal Back Liner UHMWPE Small - R | 08033390002592 |
| 1377.50.010 | SMR Metal Back Liner UHMWPE - Standard | 08033390002608 |
| 1377.50.020 | SMR Metal Back Liner UHMWPE - Small | 08033390002615 |
| 1377.50.030 | SMR Metal Back Liner UHMWPE - Large | 08033390002622 |
What are the risks?
If you have an implanted SMR MB L1 Liner you may be at higher risk of requiring revision surgery. Symptoms of device failure may include:
- Any new or worsening pain or swelling
- Inability to bear weight
- Grinding
- Weakness around your implanted device
The TGA does not recommend removal of the SMR MB L1 Liner from patients who do not have any symptoms.
What should patients do?
Contact your surgeon or health care provider if you have a SMR MB L1 Liner implanted, and you experience any of the symptoms mentioned in the ‘What are the risks’ section above in your implanted device.
What should health professionals do?
Monitor patients who have the SMR MB L1 Liner implanted in the anatomic configuration for potential device wear or bone loss. Consider performing X-rays to further evaluate a patient and their implanted device if you suspect a problem with the SMR MB L1 Liner.
In patients who may have worsening symptoms, based on clinical exam and on a case-by-case basis, discuss the benefits and risks of all relevant treatment options with your patients.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We 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.