ENGAGE 1-10011-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556873090), received between Nov 14, 2022 and Oct 16, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 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-1671-2023 · 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.

• InjuryOct 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A KNEE SURGERY HAD BEEN PERFORMED A YEAR AGO, THE PATIENT EXPERIENCED PAIN. IMAGES WERE TAKEN AND IT WAS FOUND THAT THE ENGAGE TIBIAL ANCHOR STEM SZ 3-4 FRACTURED AND THE ENGAGE POROUS TIBIAL TRAY SZ 4-LT MED SUBSIDED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) SEP, IN WHICH THE COMPONENTS WERE REMOVED AND A PRIMARY KNEE WAS IMPLANTED WITH TJO. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 17939800 ↗
• InjuryMay 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, EIGHT MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN. A POST-OPERATIVE X-RAY SHOWED RADIOLUCENCY AROUND THE ANCHOR AND FRACTURE OF THE ANCHOR. BASED ON THE X-RAYS PROVIDED, THE IMPLANT WAS MALPOSITIONED WITH THE TRAY NOT FULLY SEATED ANTERIORLY. LOADING OF THE IMPLANT DURING NORMAL ACTIVITY WOULD RESULT IN HIGHER THAN NORMAL FORCES GENERATED ON THE ANCHOR COMPONENT, CAUSING A LEVERING EFFECT. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY TO TKA ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 17010869 ↗
• MalfunctionNov 14, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, SURGEON TRIED TO IMPLANT THE TIBIAL ANCHOR STEM SIZE 3-4 AND IT WOULD NOT FIT AND AS THE DOCTOR PUSHED THE INSERTER HARDER, THE ANCHOR STEM CAUGHT THE EDGE OF SOMETHING AND BEGAN TO BEND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15791785 ↗

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-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-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