MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 77 Advance II Modular Tibial Bases because they are experiencing higher than expected revision rates due to component loosening.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening."
Plain-English summary
MicroPort Orthopedics Inc. is recalling 77 units of the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES (REF KTTIHA41, SIZE 4+). These are sterile, HA-coated, porous-surface tibial bases intended for cementless use in total knee arthroplasty systems.
The recall was initiated because the devices are experiencing a higher than expected revision rate as a result of component loosening. The affected units were distributed worldwide only to Australia, Austria, France, Italy, Spain, and the United Kingdom.
Patients who have received this specific implant should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if further evaluation or intervention is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 77
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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