ENGAGE 1-10003-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556872987), received between May 9, 2022 and Jun 4, 2024 — classified as 6 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-1670-2023 · 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.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A ENGAGE TIBIAL ANCHOR STEM SZ 3-4, ENGAGE POROUS FEMORAL SZ 4-RT MED, ENGAGE POROUS TIBIAL TRAY SZ 3-RT MED AND THE ENGAGE TIBIAL INSERT SZ 3-RT MED 9MM WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 19459857 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, A REVISION SURGERY HAD TO BE PERFORMED ON (B)(6) 2023 BECAUSE THE PATIENT HAD PAIN IMMEDIATELY AFTER IMPLANTATION THAT DID NOT SUBSIDE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17564731 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PARTIAL KNEE REPLACEMENT SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT REPORTED WEIGHT BEARING PAIN AT THE JOINT LINE 6 MONTHS POST-OP. SURGEON RECOMMENDED PATIENT TO WAIT AS PRIOR EXPERIENCE AND LITERATURE SUGGESTS THAT PAIN WOULD RESOLVE AS IMPLANTS SETTLED IN OVER TIME. PATIENT WAS REPORTEDLY NOT WILLING TO WAIT AND OPTED FOR A REVISION TO A TKA. SURGEON NOTED THAT HER LONG LIMB ALIGNMENT POST-SURGERY WAS ¿NOT THAT GREAT¿. PATIENT WAS SUCCESSFULLY CONVERTED TO A CEMENTED PRIMARY TKA ON (B)(6) 2021 WITH NO AUGMENTS AND MINIMAL BONE LOSS DUE TO THE REVISION PROCEDURE. ALSO, SURGEON NOTED THAT PATIENT MAY NOT HAVE BEEN A GOOD CANDIDATE FOR CEMENTLESS UKA AS SHE HAD A TIBIA VARA DEFORMITY IN HER LEFT TIBIA THEY MAY HAVE CONTRIBUTED TO HER PAIN.

  Patient problems: Pain

  MAUDE report 17011275 ↗
• InjuryApr 13, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER AN UKR SURGERY WAS PERFORMED IN JUNE OF 2022 USING AN ENGAGE SYSTEM, THE PATIENT HAD PERSISTENT PAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, ON WHICH THE ENGAGE POROUS FEMORAL SZ 4-RT MED DEVICE WAS FOUND TO BE RELATIVELY LOOSE WITH JUST FIBROUS ON-GROWTH. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration

  MAUDE report 16735882 ↗
• InjuryJan 18, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 16199481 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND DEVELOPED A SUTURE ABSCESS 6-7 WEEKS POSTOPERATIVELY. A REVISION SURGERY WITH AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. AS PART OF THE INTERVENTION PERFORMED, THE FEMORAL COMPONENT AND THE TIBIAL INSERT WERE REMOVED WITH STANDARD INSTRUMENTATION AND REPLACED WITH NEW CEMENTED IMPLANTS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Abscess; Arthralgia; Pain

  MAUDE report 14335942 ↗

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-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)
• 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