ENGAGE 1-10003-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556872970), received between Oct 5, 2022 and Jan 2, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT MEDIAL UKR ON (B)(6) 2022 BECAUSE THE PATIENT SUFFERED AN INTRACTABLE ARTHRITIC KNEE PAIN WHICH HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT. IN ADDITION, PATIENT ALSO HAS EXPERIENCED RIGHT KNEE PAIN. AN ENGAGE PARTIAL KNEE SYSTEM WAS IMPLANTED AND THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. FURTHERMORE, ON (B)(6) 2023 PATIENT UNDERWENT ARTHROCENTESIS/ASPIRATION FOLLOWED BY AN INJECTION OF EUFLEXXA. ADDITIONALLY, ON (B)(6) 2023 BONE SCAN SEEMS POSITIVE ON ALL THREE PHASES FOR ASYMMETRIC RADIOTRACER ACCUMULATION ADJACENT TO THE TIBIAL COMPONENT OF THE PATIENT'S MEDIAL UNICOMPARTMENTAL ARTHROSCOPY, MOST SUGGESTIVE OF HARDWARE LOOSENING (ASEPTIC VERSUS SEPTIC). THE SYSTEM WAS RECALLED AND THE PATIENT IS HAVING UNSPECIFIED ISSUES AND TO DATE IT IS UNKNOWN IF THE WHETHER CLAIMANT HAS BEEN REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.

  Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Pain

  MAUDE report 21060221 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A UKA SURGERY PERFORMED ON (B)(6) 2021, WHERE A POROUS COATED FEMORAL COMP, SIZE 3-LEFT MEDIAL, A POROUS TIBIAL TRAY SIZE 2-LEFT MEDIAL AND A TIBIAL INSERT SIZE 2-LEFT MED 9MM WERE IMPLANTED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE SYSTEM FOR A TKA. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15546897 ↗

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-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-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-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)