ENGAGE 1-10011-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556873106), received between May 8, 2022 and Sep 5, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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-1671-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA REVISION SURGERY, THE ENGAGE TIBIAL ANCHOR STEM SZ 5-6 WAS DIFFICULT TO DISENGAGE. THE WINDOW IN THE ANCHOR COULD NOT BE FREED OF BONE FOR THE HOOK TO LATCH ONTO. AFTER MULTIPLE EFFORTS TO REMOVE THE ANCHOR, A BONE TAMP WAS USED TO LIFT THE TIBIAL BASE PLATE OFF WITH THE ANCHOR STILL INTACT. NO AUGMENTS WERE NEEDED ON THE TIBIAL, A 12MM POLY WAS USED TO MAKE UP FOR THE HEAVY TIBIA CUT DUE TO THE DEFICIT FROM THE ANCHOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684933 ↗
• 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 17014788 ↗
• 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 17012009 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PARTIAL RIGHT KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6)2020 (DOCUMENTED UNDER (B)(4)), THE PATIENT EXPERIENCED UNEXPLAINED PAIN AROUND 5-MONTHS POST-OPERATION. X-RAY AND CT IMAGING SHOWED NO EVIDENCE OF PATIENT INJURY OR DEVICE MALFUNCTION. IMPLANTS WERE INTACT, WELL PLACED, AND THE SURROUNDING BONE HAD NO EVIDENCE OF DAMAGE. CT SHOWED GOOD BONE APPROXIMATION OF THE IMPLANTS. EVEN THOUGH, DUE TO THE PAIN, REVISION SURGERY WAS CONDUCTED ON (B)(6)2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17011278 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 6 MONTHS AFTER UNICOMPARTMENTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY FROM CEMENTLESS UKA TO CEMENTED UKA ON (B)(6) 2021. THE IMPLANTS WERE REMOVED WITHOUT ISSUE AND THERE WAS NO REPORTED DAMAGE TO THE IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 17011178 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SIX (6) MONTHS AFTER AN UKR HAD BEEN PERFORMED ABOUT 6 MONTHS AGO WITH AN ENGAGE SYSTEM, THE PATIENT WAS EXPERIENCING KNEE PAIN. THE PHYSICIAN CONSIDERED THAT THE ANCHOR MIGHT HAVE BEEN ADDING EXTRA FORCES AND STRESS IN THE TIBIA. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022. SINCE THE TIBIAL COMPONENT SHOULD HAVE BEEN GROWN IN, THE ANCHOR WAS TAKEN OUT TO CHECK IF THAT HELPED MITIGATE THE PAIN. THE VOID WAS FILLED WITH BONE GRAFT. THE REST OF THE PROSTHESIS WAS LEFT INTACT. PATIENT'S CURRENT HEALTH STATUS IS UNDISCLOSED.

  Patient problems: Implant Pain; Pain

  MAUDE report 16098454 ↗
• InjuryMay 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A CEMENTLESS UNICOMPARTMENTAL RIGHT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED SUBSIDENCE OF THE TIBIAL TRAY AND THE FRACTURE OF THE BLADE REGION OF THE TIBIAL ANCHOR. POSTOPERATIVE X-RAYS CONDUCTED ON AN UNSPECIFIED TIME FRAME SUGGEST A MALPOSITION OF THE FEMORAL COMPONENT RESULTING IN EDGE LOADING OF THE TIBIAL TRAY. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE COMPONENTS FROM THE UKA PROSTHESIS CONSTRUCT WERE EXPLANTED AND REPLACED WITH AN UNSPECIFIED SYSTEM. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14332633 ↗

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-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