ENGAGE 1-50042-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556874363), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.

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

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. 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.

• MalfunctionDec 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE INSERT TRIAL SZ 1 LEFT MED 9MM BROKE. PARTS WERE ALL RETRIEVED. SURGERY WAS PERFORMED, WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819815 ↗

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-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
• 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);