ENGAGE 1-10003-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556873007), received between May 9, 2022 and Apr 10, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNICOMPARTMENTAL KNEE ARTHROPLASTY WITH AN ENGAGE SYSTEM, THE PATIENT UNDERWENT REVISION SURGERY FOR UNKNOWN REASONS AND THE FEMORAL COMPONENT WAS EXPLANTED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Discomfort; Inadequate Osseointegration; Insufficient Information

  MAUDE report 16709689 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN FOR A LONG DURATION OF TIME. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A ENGAGE POROUS FEMORAL SZ 5-RT MED, POROUS TIBIAL TRAY SIZE 6-RIGHT MEDIAL, ENGAGE TIBIAL INSERT SZ 6-RT MED 9MM AND ENGAGE TIBIAL ANCHOR STEM SZ 5-6 WERE REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 16089355 ↗
• InjuryMay 9, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT BEGAN EXPERIENCING SOME DISCOMFORT. POSTOPERATIVE X-RAYS PERFORMED DURING FOLLOW UP SHOWED THE TIBIA COLLAPSED ANTERIORLY INTO VALGUS WITH "BLOW-OUT" OF MEDIAL TIBIAL. THE SURGEON STATED THAT THE FEMORAL COMPONENT WAS PLACED MORE MEDIALLY THAN DESIRED DUE TO PRE-EXISTING TIBIA VARA DEFORMITY, LEADING TO EDGE LOADING ON THE TIBIA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE SURGEON DECIDED TO REMOVE ALL THE ELEMENTS FROM THE PROSTHESIS CONSTRUCT AND REPLACE THEM WITH A FULL TKA SYSTEM. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Discomfort

  MAUDE report 14332802 ↗

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-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-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)