| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00770-1 |
| Product Name/Description |
seleXys TH+ and seleXys TPS acetabular shells
(acetabular component for the joint hip prosthesis)
seleXys TH+
Catalogue number range: 55.42.0142 - 55.42.0164
seleXys TPS
Catalogue number range:: 55.40.0042 - 55.40.0064
ARTG number: 122258 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Mathys Orthopaedics Pty. Ltd. Is issuing this hazard alert for its seleXys TH+ and TPS acetabular shells used in total hip arthroplasty due to higher than expected revision rates. A detailed analysis of the AOA NJRR data in April 2015 showed that the individual revision rate of seleXys TPS acetabular shells was 1.79 revisions per 100 component years and the revision rate of seleXys TH+ acetabular shells was 4.28 revisions per 100 component years. The analysis of the registry data identified a higher than expected rate of revision due to early loosening/lysis with the seleXys TH+ and seleXys TPS acetabular shell. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Mathys ceased supply of seleXys TH+ and seleXys TPS acetabular shells in Australia in April 2013 and June 2014, respectively. Mathys is recommending that surgeons maintain their routine follow-up protocol for patients who have undergone hip arthroplasty. The majority of additional revisions have been due to loosening/lysis, bone fracture, dislocation and pain. You may wish to consider more frequent or additional follow-up, but revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. For further information, please see https://www.tga.gov.au/alert/selexys-th-and-tps-acetabular-shells-used-hip-replacements . This action has been closed-out on 20/06/2016. |
| Contact Information |
02 9417 9200 - Mathys Medical |