Engage Partial Knee System 1-50061-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B6951500610020), received between May 13, 2021 and May 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF A TIBIAL ANCHOR GUIDE SCREW BROKE OFF WHILE IMPACTING THE TIBIAL ANCHOR IMPLANT INTO THE TIBIA. THE TIBIAL ANCHOR IMPLANTATION WAS COMPLETED SUCCESSFULLY. THE SURGEON LEFT THE TIP OF THE SCREW IN THE TIBIAL TRAY IMPLANT, AS IT WAS FULLY CONTAINED INSIDE THE MATING THREADED AREA OF THE TIBIAL TRAY COMPONENT. NO SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE CONSEQUENCES FROM THE EVENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11821281 ↗

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-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);
• 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