TC-PLUS 75005186Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996073614), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 injury.

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

9 other recalls cover devices cleared under the same FDA submission (K000666); they may or may not involve this specific model.

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 16, 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.

• InjuryJan 17, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, A HIGH-THICKNESS TC-PLUS INSERT DISSOCIATED FROM THE TIBIAL BASEPLATE AS THE FIXATION SCREW FRACTURED. A REVISION SURGERY WAS REQUIRED TO ADDRESS THIS EVENT. FURTHER DETAILS ARE UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Arthralgia; Failure of Implant; Fall; Joint Laxity; Pain; Synovitis

  MAUDE report 16189316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000666. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
• Z-0016-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 13mm, Model 25428
• Z-0019-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
• Z-0017-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
• Z-0014-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert 2; 15mm, Model 25309
• Z-0015-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 11mm, Model 25427
• Z-0013-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
• Z-0126-06 · Feb 22, 2005 · Terminated
  TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
• Z-0017-04 · Apr 17, 2003 · Terminated
  TC-PLUS Solution Tibial Component-- Symmetric