ENGAGE 1-10003-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556873021), received between Apr 27, 2022 and Aug 14, 2023 — classified as 4 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 16, 2026.

Recalls naming this device

1. May 2, 2023Open, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UKA SURGERY WAS PERFORMED ON (B)(6) 2022 WITH AN ENGAGE SYSTEM, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH CONVERSION TO TKA WAS CONDUCTED BY PLACING A JOURNEY II CONSTRUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17540978 ↗
• InjuryMay 24, 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 A UKA HAD BEEN PERFORMED ON AN UNSPECIFIED DATE WITH AN ENGAGE PARTIAL KNEE SYSTEM, THE PATIENT EXPERIENCED PAIN. A REVISION SURGERY WAS CONDUCTED TO ADDRESS THE ADVERSE EVENT. CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 16994421 ↗
• InjuryMay 9, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY COMBINED WITH AN ACL RECONSTRUCTION HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED THE RUPTURE OF THE ACL GRAFT. TO TREAT THIS ADVERSE EVENT, AN ADDITIONAL SURGERY AND CONVERSION TO A TKA WAS PERFORMED ON (B)(6) 2022 DUE TO GLOBAL KNEE INSTABILITY. DURING THIS PROCEDURE, ALL THE UKA DEVICES FROM THE CONSTRUCT WERE EXPLANTED AND REPORTED TO BE WELL-FIXED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14342090 ↗
• InjuryApr 27, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER AN UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PERSISTENT PAIN AND LOOSENING OF THE FEMORAL COMPONENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE SURGEON REVISED THE FEMORAL COMPONENT TO A NEW ENGAGE CEMENTED FEMORAL COMPONENT. INTRAOPERATIVELY, THE SURGEON FOUND A MINIMAL BONY-INGROWTH ON THE ORIGINAL FEMORAL COMPONENT, MAKING IT RELATIVELY EASY TO REMOVE WITHOUT MUCH BONE LOSS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Pain

  MAUDE report 14227588 ↗

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-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-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