ENGAGE 1-10012-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556873175), received between May 7, 2022 and May 9, 2022 — classified as 2 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-1672-2023 · 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.

• InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER AN UNCEMENTED UNICOMPARTMENTAL LEFT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED JOINT INSTABILITY, PAIN AND DISCOMFORT. X-RAYS PERFORMED FOUR (4) WEEKS POSTOPERATIVELY SHOWED THAT THE TIBIAL TRAY WAS NOT FULLY SEATED UPON IMPLANTATION AND THAT THERE WAS A GAP POSTERIORLY. THE SURGEON TRIED A BONE STIMULATOR ON THE PATIENT TO SEE IF THAT WOULD FACILITATE BONE INGROWTH. ADDITIONAL X-RAYS PERFORMED ELEVEN (11) MONTHS POSTOPERATIVELY SHOWED PATHOLOGIC RADIOLUCENT LINES WITH NON-UNIFORM THICKNESS UNDER TRAY THAT WERE PROGRESSIVE IN NATURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO CONVERT THE KNEE INTO A FULL TKA SYSTEM. DURING THIS PROCEDURE, THE SURGEON NOTED THAT THE FEMORAL COMPONENT HAD SOME INGROWTH ON THE DISTAL SURFACE, BUT VERY LITTLE ON THE POSTERIOR SURFACE WITH PRIMARILY FIBROUS INGROWTH PREDOMINANTLY. SIMILARLY, THE TIBIAL TRAY SHOWED BONE INGROWTH NEAR THE ANTERIOR PEG AND MEDIALLY UNDER THE ANCHOR, WITH VERY LITTLE BONE INGROWTH ON THE POSTERIOR PART OF THE TRAY. THE TIBIAL INSERT SHOWED LOCAL DEFORMATION WHERE THE FEMUR CONTACTED THE INSERT AND HAD DEVELOPED A GROOVE. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Discomfort; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 14333326 ↗
• InjuryMay 7, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED SUBSIDENCE INTO VARUS OF THE TIBIAL TRAY 3 MONTHS POSTOPERATIVELY, AS NOTED FROM X-RAYS TAKEN DURING FOLLOW UP. THE PATIENT HAS NOT EXPERIENCED ANY CLINICAL SYMPTOMS AS A CONSEQUENCE OF THE TIBIAL TRAY SUBSIDENCE. THE SURGEON IS MONITORING THE PROGRESS OF THE PATIENT'S OUTCOME.

  Patient problems: Arthralgia; Deformity/ Disfigurement; Failure of Implant; Pain

  MAUDE report 14327866 ↗

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-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)