MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural failure (component loosening) in a load-bearing medical device, which aligns with the rubric criterion for 'structural vehicle defect' or significant injury/property-damage reports, warranting a Severe classification.
Plain-English summary
MicroPort Orthopedics Inc. is recalling the Advance II Modular Tibial Base with Screw Holes (Reference KTTIHA30, Size 3 STD). The device is a porous, HA-coated tibial base intended for cementless fit in total knee arthroplasty.
The recall was initiated because the product is experiencing a higher than expected revision rate as a result of component loosening. The source text does not specify the number of reported injuries, illnesses, or deaths associated with this issue.
A total of 169 units were distributed worldwide to Australia, Austria, France, Italy, Spain, and the United Kingdom. Patients who have had this specific device implanted should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if any follow-up care or revision surgery is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 169
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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