Oxford Partial Knee-Uncemented Tibial Component Porous +Ha

Starting date:

March 20, 2017

Posting date:

April 13, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63000

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  Reason
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  Affected products

Reason

Analysis of complaint rates identified a world-wide occurrence of 0.12% of patients experiencing tibial plateau fractures.

Analysis of the reported complaints has shown that should a tibia fracture occur, it is identified by the treating orthopedic consultant within an average of 25 days from primary surgery, and available data indicate that 17% of those fractures have been treated conservatively.

The oxford cementless tibial trays have been manufactured according to pre-defined specifications. An investigation into the cause of the reported tibial plateau fractures has revealed the importance that certain steps described in the applicable surgical technique are followed to reduce the risk of tibia plateau fractures. By means of this notice we would like to emphasize the importance of adhering to the applicable surgical technique and the appropriate sections in the instruction for use packaged with the products.

Affected products