| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00761-1 |
| Product Name/Description |
PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)
Product Codes:
CHRA-910-38/14-WW (Size 38-14)
CHRA-910-41/15-WW (Size 41-15)
CHRA-910-41/18-WW (Size 41-18)
CHRA-910-44/16-WW (Size 44-16)
CHRA-910-44/19-WW (Size 44-19)
CHRA-910-44/17-WW (Size 47-17)
CHRA-910-47/20-WW (Size 47-20)
CHRA-910-50/18-WW (Size 50-18)
CHRA-910-50/21/WW (Size 50-21)
CHRA-910-53/19-WW (Size 53-19)
CHRA-910-53/22-WW (Size 53-22)
CHRA-910-56/21-WW (Size 56-21)
ARTG: 149178 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Ascension Orthopedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. Most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. Excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. High impact activity may cause loosening or fracture of the implant. The breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The implanting surgeons are advised that the affected patients should be followed up in accordance to standard clinical practices with radiographic evaluation of the shoulder being conducted at each follow-up visit. LMT Surgical Pty Ltd is advising that future supply of the product in Australia will not occur before appropriate corrective actions are implemented. It is expected that this corrective action will take several months to complete. For more details, see http://www.tga.gov.au/safety/alerts-device-pyrotitan-130812.htm |
| Contact Information |
07 3367 6600 - LMT Surgical |