ENGAGE 1-10012-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556873182), received between May 9, 2022 and Dec 19, 2023 — classified as 4 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-1672-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS THAT, AFTER A UKA HAD BEEN PERFORMED ON (B)(4) 2023, THE PATIENT UNDERWENT A REVISION SURGERY TO A TKA ON (B)(4) 2023, DUE TO THE ENGAGE POROUS TIBIAL TRAY SZ 4-RT MED NOT BEING INGROWN AND HAD STARTUP PAIN. IN ADDITION, ONE (1) ENGAGE TIBIAL INSERT SZ 4-RT MED 9MM, ONE (1) ENGAGE POROUS FEMORAL SZ 5-RT MED AND ONE (1) ENGAGE POROUS FEMORAL SZ 5-RT MED WERE REMOVED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18359968 ↗
• InjuryMay 26, 2023Malposition of Device; Malposition of Device

  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 17014929 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT BEGAN EXPERIENCING SOME DISCOMFORT. POSTOPERATIVE X-RAYS PERFORMED DURING FOLLOW UP SHOWED THE TIBIA COLLAPSED ANTERIORLY INTO VALGUS WITH "BLOW-OUT" OF MEDIAL TIBIAL. THE SURGEON STATED THAT THE FEMORAL COMPONENT WAS PLACED MORE MEDIALLY THAN DESIRED DUE TO PRE-EXISTING TIBIA VARA DEFORMITY, LEADING TO EDGE LOADING ON THE TIBIA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE SURGEON DECIDED TO REMOVE ALL THE ELEMENTS FROM THE PROSTHESIS CONSTRUCT AND REPLACE THEM WITH A FULL TKA SYSTEM. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Discomfort

  MAUDE report 14332826 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNCEMENTED RIGHT KNEE UNICOMPARTMENTAL ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT START EXPERIENCING PAIN WHEN WALKING. POSTOPERATIVE RADIOGRAPHIC IMAGING APPEAR TO SHOW A MALPOSITION OF THE TIBIAL TRAY AND A MEDIALIZED FEMORAL COMPONENT RESULTING IN EDGE LOADING OF TIBIAL TRAY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE TIBIAL TRAY WAS EXPLANTED AND REPLACED WITH A NEW CEMENTED SIZE 4 TIBIAL TRAY AND THE TIBIAL INSERT WAS UPSIZED FROM A 9MM TO A 11MM. THE PATIENT'S OUTCOME AND CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Deformity/ Disfigurement

  MAUDE report 14332691 ↗

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-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)