TC-PLUS 75005997Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996008708), received between Sep 4, 2018 and Jun 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA ON HER LEFT KNEE IN 2012, THE PATIENT FELT KNEE INSTABILITY, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGE A TC PRIM TIBIAL INSERT TC CR STAND 6/11, DUE TO, THE INSERT HE/SHE WAS CARRYING WAS BROKEN. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION TO THE SMITH + NEPHEW BARCELONA WAREHOUSE.

  Patient problems: Joint Laxity

  MAUDE report 12043068 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OF THE TIBIAL INSERT TC CR STAND 6/11.

  Patient problems: Injury

  MAUDE report 7844471 ↗

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-0017-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
• Z-0018-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
• Z-0014-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert 2; 15mm, Model 25309
• Z-0019-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
• Z-0013-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
• Z-0015-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 11mm, Model 25427
• Z-0016-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 13mm, Model 25428
• 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