ENGAGE 1-10012-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556873151), received between Jan 3, 2023 and Feb 27, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2 reports).

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-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.

• InjuryFeb 27, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER A LEFT ENGAGE UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) WAS PERFORMED IN (B)(6) 2022, THE PATIENT EXPERIENCED EXCESSIVE PAIN, EVEN AFTER ATTENDING THERAPY. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY CONDUCTED ON (B)(6) 2023. DURING THE SURGERY IT WAS NOTICED THAT THE FEMORAL COMPONENT WAS LOOSE WITH ZERO BONE INGROWTH, THE TIBIAL COMPONENT HAD MINIMAL BONE INGROWTH AND PATHOLOGICAL STRESS SHIELDING AROUND THE ANCHOR, AND THERE WAS SIGNIFICANT POLY WEAR. THE PATIENT REPORTED TO HAVE A GREAT RECOVERY.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 16448391 ↗
• InjuryJan 3, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A UKR WAS PERFORMED ON (B)(6) 2021, THE ENGAGE POROUS TIBIAL TRAY SZ 3-LT MED DID NOT GROW INTO THE PATIENT'S BONE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT WERE ALL THE DEVICES WERE EXPLANTED. NO FURTHER DETAILS AVAILABLE AT THIS MOMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16090124 ↗

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)