ENGAGE 1-10012-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556873199), received between May 8, 2022 and Mar 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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-1672-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ENGAGE POROUS TIBIAL TRAY SZ 5 LT MED FAILURE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ALL COMPONENTS WERE REMOVED AND CONVERTED TO A TOTAL KNEE ARTHROPLASTY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21543048 ↗
• InjuryAug 12, 2024Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A LEFT PKA SURGERY WITH THE ENGAGE CEMENTLESS PARTIAL KNEE SYSTEM, THE PATIENT EXPERIENCED A TIBIA LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19967115 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PARTIAL RIGHT KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED UNEXPLAINED PAIN AROUND 5-MONTHS POST-OPERATION. X-RAY AND CT IMAGING SHOWED NO EVIDENCE OF PATIENT INJURY OR DEVICE MALFUNCTION. IMPLANTS WERE INTACT, WELL PLACED, AND THE SURROUNDING BONE HAD NO EVIDENCE OF DAMAGE. CT SHOWED GOOD BONE APPROXIMATION OF THE IMPLANTS. EVEN THOUGH, DUE TO THE PAIN, REVISION SURGERY WAS CONDUCTED ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17014865 ↗
• 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 17011373 ↗
• InjuryMay 10, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING UKA SURGERY, THE TIBIAL ANCHOR WAS IMPLANTED WITH THE JOINT IN EXTENSION, AND THE SURGEON DID NOT NOTICE ANY GAP BETWEEN THE TIBIAL TRAY AND THE TIBIAL BONE SURFACE, AS THEY BOTH APPEAR TO SIT FLUSH. WHEN GOING TO JOINT FLEXION, THE POROUS TIBIAL TRAY SIZE 5-LEFT MEDIAL POP UP IN THE BACK, AND A GAP BETWEEN THE TIBIAL TRAY AND THE TIBIAL BONE SURFACE WAS EVIDENT. AFTER THIS INCIDENT, THE SURGEON DECIDED TO REMOVE THE TIBIAL ANCHOR AND A CHANGE IN SURGICAL TECHNIQUE WAS PERFORMED TO SWITCH TO A CEMENTED TIBIAL TRAY. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345779 ↗
• InjuryMay 8, 2022Migration; Migration

  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 14332625 ↗

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-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)
• 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