Engage Partial Knee System 1-10012-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B6951100122500), received between Mar 27, 2021 and Mar 27, 2021 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K190439); 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS COMPLAINING OF ANTERIOR KNEE PAIN AFTER FOUR WEEKS POST-OP. THE SURGEON REVIEWED HER X-RAYS AND DETERMINED THAT THE PATIENT EXPERIENCED ANTEROMEDIAL TIBIAL SUBSIDENCE. THE SURGEON PROVIDED TWO OPTIONS TO PATIENT; 1) NON-WEIGHT BEARING FOR A FEW WEEKS TO LET THE BONE HEAL, OR 2) REVISE FROM PARTIAL KNEE ARTHROPLASTY TO TOTAL KNEE ARTHROPLASTY (TKA). THE PATIENT ELECTED TO HAVE A REVISION PROCEDURE. THE PROCEDURE WAS PERFORMED WITHOUT ANY FURTHER ISSUES.

  Patient problems: Pain

  MAUDE report 11579367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190439. One submission often covers many models, so check the product and lot details in each record.

• Z-1673-2023 · May 2, 2023 · Open, Classified
  Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c)
• Z-1672-2023 · May 2, 2023 · Open, Classified
  Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-1
• Z-1670-2023 · May 2, 2023 · Open, Classified
  Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial);
• Z-1671-2023 · May 2, 2023 · Open, Classified
  Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6