| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00111-1 |
| Product Name/Description |
Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration)
Item Numbers: 00-5850-012-95 & 00-5850-013-95
ARTG Number: 198424 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer has received 13 complaints since 2007 related to hyper-extension. This represents a complaint rate of approximately 0.4%. Of the 13 complaints there were 9 patients involved due to repeat occurrences with multiple patients. In addition, analysis of the explanted polyethylene insert found that it typically exhibited anterior deformation in these 9 patients. Based on the investigation of these complaints, Zimmer determined that updates to the labelling associated with the Zimmer Segmental System were required to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is updating the applicable surgical technique (97-5850-004-00) and instructions for use (87-6203-755-23) and is advising surgeons that if a patient is symptomatic with instability or pain associated with hyperextension of approximately 15 degrees or more, surgeon evaluation is recommended. Zimmer is also working on an enhanced design that will be offered in addition to the current polyethylene inserts. |
| Contact Information |
1800 803 263 - Zimmer Nationwide Customer Service |