| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00045-1 |
| Product Name/Description |
SMR MB L1 Liner
Product Codes:1377.50.005, 1377.50.010, 1377.50.020, 1377.50.030
Product Names: SMR Metal Back Liner UHMWPE Small - R, SMR Metal Back Liner UHMWPE - Standard, SMR Metal Back Liner UHMWPE - Small,
SMR Metal Back Liner UHMWPE - Large
ARTG 221714 (Lima Orthopaedics Australia Pty Ltd - SMR MB Liner UHMWPE - Prosthesis, internal, joint, shoulder, glenoid component) - Cancelled |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Specific to the product codes as listed, 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. The Cumulative Percent Revision (CPR) rate after the first post-operative year was 6.0% compared to 1.8% for other total stemmed anatomic shoulder replacements, rising to 20.5% at 10 years (vs 7.9% for other total stemmed anatomic shoulder replacements).
Lima Orthopaedics has cancelled the registration of the SMR MB L1 Liner, meaning the SMR/SMR L1 total anatomic stemmed shoulder (uncemented) system is no longer available for implantation as a primary procedure in Australia. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Recommendation to HCP's
• SMR MB L1 Liner is no longer available to be implanted (withdrawn Nov 2023).
• The TGA doesn't recommend removal of the SMR MB L1 Liner from patients who do not have any new or worsening pain or symptoms.
• Monitor patients who have the SMR MB L1 Liner implanted in the anatomic configuration for potential device wear or bone loss.
• 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 patients.
Recommendations to Patients:
• Contact your surgeon or health care provider if you have a SMR MB L1 Liner implanted and you have any new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around your implanted device.
This action has been closed out on 22/04/2024 |
| Contact Information |
1800 565 815 - Lima Orthopaedics |