ENGAGE 1-50085-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556875063), received between Mar 13, 2023 and Apr 29, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K190439); 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A CONVERSION OF AN ENGAGE UNI TO A TKA SURGERY, IT WAS NOTICED THAT THE HOOK OF ONE (1) ANCHOR REMOVAL TOOL WAS BROKEN OFF. THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A DIFFERENT SURGICAL TECHNIQUE, SINCE THE TEAM HAD TO BURR AWAY THE BONE AROUND THE ANCHOR AND PRY THE WHOLE TIBIA OFF WHILE IT WAS STILL ATTACHED TO THE ANCHOR. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928035 ↗
• MalfunctionApr 16, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING AN UKR REVISION SURGERY, THE ANCHOR REMOVAL TOOL BROKE OFF INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED . CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748728 ↗
• InjuryMar 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE PHYSICIAN HAD TROUBLE ENGAGING ONE (1) ANCHOR REMOVAL TOOL INTO THE ANCHOR. THIS ISSUE REQUIRED ADDITIONAL BONE CUTS IN ORDER TO EXPLANT THE DEVICES. THE PATIENT RECEIVED A TKA SYSTEM IN EXCHANGE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 16645370 ↗
• MalfunctionMar 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY DUE TO LINGERING PAIN, THE PHYSICIAN HAD TROUBLE ENGAGING THE ANCHOR REMOVAL TOOL INTO THE ANCHOR. IT TOOK LONGER THAN 30 MINUTES AND ADDITIONAL BONE CUTS TO GET THE IMPLANTS OUT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THIS PROBLEM.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16645346 ↗
• InjuryMar 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, THE PHYSICIAN HAD TROUBLE ENGAGING ONE (1) ANCHOR REMOVAL TOOL INTO THE ANCHOR. THIS ISSUE REQUIRED ADDITIONAL BONE CUTS IN ORDER TO EXPLANT THE DEVICES. THE PATIENT RECEIVED A TKA SYSTEM IN EXCHANGE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 16644929 ↗
• InjuryMar 30, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY DUE TO PERSISTENT PAIN, THE PHYSICIAN HAD TROUBLE ENGAGING ONE (1) ANCHOR REMOVAL TOOL INTO THE ANCHOR. THIS ISSUE REQUIRED ADDITIONAL BONE CUTS IN ORDER TO EXPLANT THE DEVICES. THE PATIENT RECEIVED A COMPETITORS TKA SYSTEM IN EXCHANGE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Perforation; Unspecified Tissue Injury

  MAUDE report 16644750 ↗
• InjuryMar 13, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING A REVISION SURGERY DUE TO CHRONIC PAIN, THE PHYSICIAN HAD TROUBLE ENGAGING THE ANCHOR REMOVAL TOOL INTO THE ANCHOR. HE USED THE CUTTER AND CHISEL A COUPLE OF TIMES THROUGH THE ALIGNMENT TOOL AND A SMALL OSTEOTOME TO MAKE A BIGGER WINDOW FOR THE REMOVAL TOOL TO GO INTO BUT IT DID NOT WORK. FINALLY, HE USE A BONE TAMP TO KNOCK THE IMPLANTS LOOSE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A COMPETITORS TKA SYSTEM IN EXCHANGE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16527344 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190439. One submission often covers many models, so check the product and lot details in each record.

• 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-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
• 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-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