Engage Partial Knee System 1-10003-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B6951100035100), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Installation-Related Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K190439); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2021Installation-Related Problem; Installation-Related Problem

  PATIENT WAS COMPLAINING OF KNEE PAIN AT 5-MONTHS POSTOP. 5MO POSTOP XRAYS DID NOT INDICATE ANY DEVICE FAILURE OR MALFUNCTION BUT DID PRESENT MODERATE JOINT SPACE NARROWING, FAR MEDIAL PLACEMENT OF FEMUR, VARUS ALIGNMENT AND A LATERAL GAP UNDER TIBIAL TRAY. 2WKS POST OP RADIOGRAPHS ALSO PRESENTED SIMILAR MISALIGNMENTS. REVISION WAS PERFORMED AND CONVERTED TO A TOTAL KNEE ARTHROPLASTY (ANOTHER MANUFACTURER'S PRODUCT) WITHOUT ANY FURTHER ISSUES.

  Patient problems: Pain

  MAUDE report 12246656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190439. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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