ENGAGE 1-10003-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556872949), received between May 26, 2023 and Aug 6, 2024 — classified as 2 injuries.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K190439, K230653); 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.

Recalls naming this device

1. May 2, 2023Class IIOpen, Classified

   Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

   Z-1670-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED AN USPECIFIED FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 19919034 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SIX MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY TO TKA ON (B)(6) 2021. AN ABNORMALLY HIGH POSTERIOR SLOPE OF 19 DEGREES (THE STANDARD IS 5 DEGREES) WAS PRODUCED UPON TIBIAL RESECTION, WHICH IS THE PROBABLE ROOT CAUSE THE REPORTED PAIN. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17011463 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190439, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• 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