ENGAGE 1-10012-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556873205), received between May 8, 2022 and Aug 1, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 2, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY, THE PATIENT EXPERIENCED A LOOSE TIBIAL TRAY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19888816 ↗
• InjuryJun 29, 2023Adverse 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) 2023, IN WHICH THE ENGAGE POROUS TIBIAL TRAY SZ 5-RT MED WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 17225487 ↗
• 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 "THAT" MAY HAVE CONTRIBUTED TO HER PAIN.

  Patient problems: Pain

  MAUDE report 17014971 ↗
• InjuryMay 9, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, AFTER A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY COMBINED WITH AN ACL RECONSTRUCTION HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED THE RUPTURE OF THE ACL GRAFT. TO TREAT THIS ADVERSE EVENT, AN ADDITIONAL SURGERY AND CONVERSION TO A TKA WAS PERFORMED ON (B)(6) 2022 DUE TO GLOBAL KNEE INSTABILITY. DURING THIS PROCEDURE, ALL THE UKA DEVICES FROM THE CONSTRUCT WERE EXPLANTED AND REPORTED TO BE WELL-FIXED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14342009 ↗
• InjuryMay 8, 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 EXPERIENCED WEIGHT BEARING PAIN AT THE JOINT LINE 5 MONTHS POSTOPERATIVELY. A SUBSTANTIAL AMOUNT OF RESIDUAL VARUS IN THE LONG LIMB ALIGNMENT WAS REVEALED BY POSTOPERATIVE ANTEROPOSTERIOR X-RAYS OF THE RIGHT TIBIA. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH A FULL TKA CONSTRUCT. INTRAOPERATIVELY, ALL IMPLANTS WERE WELL FIXED AND WITH A GOOD BONE INGROWTH IF POROUS COATED. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Deformity/ Disfigurement

  MAUDE report 14332483 ↗

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-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