ENGAGE 1-10012-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556873168), received between May 8, 2022 and May 9, 2022 — classified as 3 injuries.

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

• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CEMENTLESS RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT START EXPERIENCING PAIN 6 MONTHS POSTOPERATIVELY. THE PATIENT INSISTENTLY REQUESTED THE SURGEON TO REVISE HER RIGHT KNEE TO A TKA SYSTEM, DESPITE THE SURGEON BEING SATISFIED WITH THE IMPLANT POSITIONING AND THE RECOVERY PROCESS. X-RAYS TAKEN AFTER PRIMARY IMPLANTATION APPEAR TO REVEAL A SLIGHT VALGUS CON THE TIBIAL TRAY CUT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. DURING THIS PROCEDURE, ALL DEVICES FROM THE CONSTRUCT WERE EXPLANTED AND INTRAOPERATIVELY, THE WERE NOTED TO BE WELL FIXED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Deformity/ Disfigurement; Pain

  MAUDE report 14341772 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CEMENTLESS UNICOMPARTMENTAL RIGHT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A PARTIAL TIBIAL FRACTURE BELOW THE TIBIAL TRAY AS REVEALED BY ANTEROPOSTERIOR X-RAYS PERFORMED 6 WEEKS POSTOPERATIVELY. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE UKA PROSTHESIS WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 14332927 ↗
• InjuryMay 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN EVIDENT NON-DISPLACED FRACTURE BELOW THE TIBIAL TRAY COMPONENT AS REVEALED BY X-RAYS PERFORMED ON TWO (2) AND SEVEN (7) WEEKS POSTOPERATIVELY. THE SURGEON PUT THE PATIENT ON PARTIAL WEIGHT BEARING AS A MEASURE TO LET THE FRACTURE HEAL. THE PATIENT WAS REPORTED TO BE AMBULATORY AND IMPROVING ON (B)(6) 2021. FURTHER DETAILS ON THE PATIENT'S CURRENT HEALTH STATUS ARE NOT KNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 14332590 ↗

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-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);