ENGAGE 1-10003-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556873014), received between May 8, 2022 and May 26, 2023 — classified as 5 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-1670-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 6 MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY FROM CEMENTLESS UKA TO CEMENTED UKA ON (B)(6) 2021. DURING THIS SURGERY, THE ANCHOR REMOVAL TOOL TIP BROKE (DOCUMENTED UNDER (B)(4)). THE IMPLANTS WERE REMOVED WITHOUT ISSUE AND THERE WAS NO REPORTED DAMAGE TO THE IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17011137 ↗
• InjuryMay 24, 2023Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT UKA HAD BEEN PERFORMED ON (B)(6) 2021 WITH AN ENGAGE PARTIAL KNEE SYSTEM, THE PATIENT STARTED TO EXPERIENCE INCREASED PAIN THROUGHOUT PHYSICAL THERAPY. TESTING PRODUCED FINDINGS CONSISTENT WITH A BROKEN CERVICAL SCREW. THEREFORE, A REVISION SURGERY WAS CONDUCTED IN 2023 TO ADDRESS THIS ADVERSE EVENT. CURRENT HEALTH STATUS OF THE PLAINTIFF IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 16995233 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A UKA SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2021, THE PATIENT COMPLAINED OF CHRONIC PAIN. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. THE PATIENT RECEIVED A TKA SYSTEM IN EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: Arthralgia; Pain

  MAUDE report 16554464 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING REVISION SURGERY OF AN ENGAGE PARTIAL KNEE SYSTEM, ONE (1) POROUS FEMORAL COMP SIZE 5-LEFT MEDIAL, ONE (1) POROUS TIBIAL TRAY SIZE 4-LEFT MEDIAL, ONE (1) TIBIAL INSERT SIZE 4-LEFT MED 9MM AND ONE (1) TIBIAL ANCHOR STEM SIZE 3-4 WERE REMOVED AND A COMPETITOR TOTAL KNEE WAS IMPLANTED. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15923576 ↗
• InjuryMay 8, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT, AFTER A CEMENTLESS UNICOMPARTMENTAL RIGHT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED SUBSIDENCE OF THE TIBIAL TRAY AND THE FRACTURE OF THE BLADE REGION OF THE TIBIAL ANCHOR. POSTOPERATIVE X-RAYS CONDUCTED ON AN UNSPECIFIED TIME FRAME SUGGEST A MALPOSITION OF THE FEMORAL COMPONENT RESULTING IN EDGE LOADING OF THE TIBIAL TRAY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE UKA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14332612 ↗

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-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-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)