ENGAGE 1-10012-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556873212), received between May 8, 2022 and May 26, 2023 — classified as 2 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 2 most recent of 2 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, AFTER UKA SURGERY WAS PERFORMED ON (B)(6) 2021, AP X-RAYS DEMONSTRATED TIBIAL COLLAPSE WHERE TIBIAL IMPLANT WAS ROTATED IN VALGUS. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2021 (5 WEEKS POST-OP) FROM A UKA TO TKA. DURING THIS PROCEDURE, IT WAS OBSERVED THAT THE BONE QUALITY WAS VERY POOR. IT WAS DETERMINED THAT A CEMENTED TOTAL KNEE ARTHROPLASTY SHOULD HAVE BEEN PERFORMED INSTEAD AS INITIAL SURGERY, SINCE THE PATIENT WAS NOT A GOOD CANDIDATE FOR A UKA. THE SURGEON WAS ABLE TO LIFT THE TIBIAL TRAY & ANCHOR OUT OF THE PATIENT WITH A RONGEUR BY HAND. REVISION PROCEDURE FROM UKA TO TKA WAS SUCCESSFULLY COMPLETED. BASED ON THE INFORMATION PROVIDED BY 3 INDEPENDENT INDIVIDUALS, INCLUDING 2 TRAINED ORTHOPEDIC MEDICAL DOCTORS, THE CAUSE OF THE INCIDENT WAS POOR BONE QUALITY OF THE PATIENT, AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INCIDENT.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 17014958 ↗
• InjuryMay 8, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN. DURING A FOLLOW UP CONDUCTED SIX (6) WEEKS POSTOPERATIVELY, X-RAYS APPEAR TO REVEAL THAT THE TIBIAL TRAY WAS NOT FULLY SEATED ON THE TIBIAL BONE. 8 MONTHS POSTOPERATIVELY, PATHOLOGIC RADIOLUCENT LINES WITH NON-UNIFORM THICKNESS UNDER THE TIBIAL TRAY WERE PRESENT AS REVEALED BY X-RAYS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE UKA DEVICES WERE EXPLANTED AND EXCHANGED WITH A FULL TKA SYSTEM. INTRAOPERATIVELY, NO EVIDENT GAPS WERE NOTICED AT THE IMPLANT INTERFACES, BUT LIMITED BONE IN-GROWTH WAS NOTED ON THE POROUS SURFACE OF THE IMPLANTS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Pain

  MAUDE report 14332493 ↗

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)