| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00737-1 |
| Product Name/Description |
PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254
(Modular neck component of the femoral head/stem prosthesis)
All lot numbers
ARTG number: 234443 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
MicroPort Orthopaedics Inc. has identified unanticipated postoperative implant fractures related to this specific part number. These fractures are extremely rare, yet there have been 27 reports (failure rate of 0.275%) of fracture of the PHAC1254 component. All fractures involve part number PHAC1254 (Long 8-degree varus) which sees the highest bending force due to its length and therefore represents the implant in this product family with the lowest mechanical strength under clinical conditions. No implant fractures have been reported in other PRO FEMUR CoCr modular neck models. In the event the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons are advised that there is no evidence fractures can be anticipated by visual inspection or during surgery. When the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. A break will require revision surgery to correct. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. No additional patient follow-up is required however surgeons are advised to discuss the issues with their patients . This action has been closed-out on 04/05/2017. |
| Contact Information |
02 9452 7447 - Surgical Specialties |