LCS 1290-14-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295021247), received between Sep 16, 2022 and Sep 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 1997, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE LCS FOR THE RHEUMATOID ARTHRITIS OF THE RIGHT KNEE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE INSERT WAS WORN OUT. THEREFORE, A REVISION SURGERY WILL BE PERFORMED, AND THE INSERT WILL BE REPLACED. WOBBLE AND PAIN OCCURRED IN THE RIGHT KNEE JOINT DUE TO THE INSERT WEAR OVER TIME. POSSIBLE CAUSES OTHER THAN THE PRODUCT ARE WEIGHT GAIN. THE SURGEON WILL DETERMINE THE REVISION SURGERY DATE ACCORDING TO IMPLANT¿S INVENTORY STATUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15436789 ↗