ENGAGE 1-10003-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556872994), received between May 8, 2022 and May 26, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 17014878 ↗
• InjuryMar 17, 2023Mechanical Problem; Failure to Osseointegrate; Mechanical Problem; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 THE PATIENT EXPERIENCED CHRONIC PAIN AND MECHANICAL COMPLICATION OF INTERNAL KNEE PROSTHESIS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023 IN WHICH ONE (1) ENGAGE POROUS FEMORAL SZ 4-LT MED, ONE (1) ENGAGE TIBIAL INSERT SZ 4-LF MED 9MM, ONE (1) ENGAGE POROUS TIBIAL TRAY SZ 4-LT MED AND ONE (1) ENGAGE TIBIAL ANCHOR STEM SZ 3-4 WERE EXTRACTED. DR BERENDS PA MENTIONED THE IMPLANT MIGHT HAVE SET LOOSENING. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE (MEDACTA). THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 16569242 ↗
• InjuryFeb 24, 2023Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 16437031 ↗
• InjuryFeb 23, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT AFTER A LEFT ENGAGE UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) WAS PERFORMED IN (B)(6) 2022, THE PATIENT EXPERIENCED EXCESSIVE PAIN, EVEN AFTER ATTENDING THERAPY. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY CONDUCTED ON (B)(6) 2023. DURING THE SURGERY IT WAS NOTICED THAT THE FEMORAL COMPONENT WAS LOOSE WITH ZERO BONE INGROWTH, THE TIBIAL COMPONENT HAD MINIMAL BONE INGROWTH AND PATHOLOGICAL STRESS SHIELDING AROUND THE ANCHOR, AND THERE WAS SIGNIFICANT POLY WEAR. THE PATIENT REPORTED TO HAVE A GREAT RECOVERY.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 16428350 ↗
• InjuryJan 3, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A UKR WAS PERFORMED ON (B)(6) 2021, THE ENGAGE POROUS FEMORAL SZ 4-LT MED DID NOT GROW INTO THE PATIENT'S BONE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT WERE ALL THE DEVICES WERE EXPLANTED. NO FURTHER DETAILS AVAILABLE AT THIS MOMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16090095 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE AND REMOVE THE ENGAGE POROUS FEMORAL SZ 4-LT MED, THE ENGAGE TIBIAL ANCHOR STEM SZ 3-4 AND THE ENGAGE TIBIAL INSERT SZ 4-LT MED 9MM AND A ENGAGE POROUS TIBIAL TRAY SZ 4-LT MED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16050168 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED LINGERING PAIN. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY AND CONVERSION TO TKA ON (B)(6) 2022, IN WHICH THE FOLLOWING IMPLANTS WERE EXPLANTED: POROUS FEMORAL COMP SIZE 4-LEFT MEDIAL, TIBIAL ANCHOR STEM SIZE 3-4, POROUS TIBIAL TRAY SIZE 3-LEFT MEDIAL AND TIBIAL INSERT SIZE 3-LEFT MED 9MM. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. PATIENT CURRENT HEATH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 15747726 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNICOMPARTMENTAL KNEE REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED KNEE PAIN FOR OVER A YEAR SINCE SURGERY. THIS UNI WAS A PRESSFIT ENGAGE PARTIAL KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT ITS UNKNOWN. UPON TRYING TO REMOVE THE TIBIAL ANCHOR, THE ANCHOR BROKE, WHICH INCREASED THE EXPLANTATION TIME. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. SURGERY WAS COMPLETED WITH A NON-SIGNIFICANT DELAY.

  Patient problems: Arthralgia

  MAUDE report 15674642 ↗
• InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER AN UNCEMENTED UNICOMPARTMENTAL LEFT KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED JOINT INSTABILITY, PAIN AND DISCOMFORT. X-RAYS PERFORMED FOUR (4) WEEKS POSTOPERATIVELY SHOWED THAT THE TIBIAL TRAY WAS NOT FULLY SEATED UPON IMPLANTATION AND THAT THERE WAS A GAP POSTERIORLY. THE SURGEON TRIED A BONE STIMULATOR ON THE PATIENT TO SEE IF THAT WOULD FACILITATE BONE INGROWTH. ADDITIONAL X-RAYS PERFORMED ELEVEN (11) MONTHS POSTOPERATIVELY SHOWED PATHOLOGIC RADIOLUCENT LINES WITH NON-UNIFORM THICKNESS UNDER TRAY THAT WERE PROGRESSIVE IN NATURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO CONVERT THE KNEE INTO A FULL TKA SYSTEM. DURING THIS PROCEDURE, THE SURGEON NOTED THAT THE FEMORAL COMPONENT HAD SOME INGROWTH ON THE DISTAL SURFACE, BUT VERY LITTLE ON THE POSTERIOR SURFACE WITH PRIMARILY FIBROUS INGROWTH PREDOMINANTLY. SIMILARLY, THE TIBIAL TRAY SHOWED BONE INGROWTH NEAR THE ANTERIOR PEG AND MEDIALLY UNDER THE ANCHOR, WITH VERY LITTLE BONE INGROWTH ON THE POSTERIOR PART OF THE TRAY. THE TIBIAL INSERT SHOWED LOCAL DEFORMATION WHERE THE FEMUR CONTACTED THE INSERT AND HAD DEVELOPED A GROOVE. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Discomfort; Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 14333256 ↗
• InjuryMay 8, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT, AFTER A LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN. DURING A FOLLOW UP CONDUCTED SIX (6) WEEKS POSTOPERATIVELY, X-RAYS APPEAR TO REVEAL THAT THE TIBIAL TRAY WAS NOT FULLY SEATED ON THE TIBIAL BONE. 8 MONTHS POSTOPERATIVELY, PATHOLOGIC RADIOLUCENT LINES WITH NON-UNIFORM THICKNESS UNDER THE TIBIAL TRAY WERE PRESENT AS REVEALED BY X-RAYS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, ALL THE UKA DEVICES WERE EXPLANTED AND EXCHANGED WITH A FULL TKA SYSTEM. INTRAOPERATIVELY, NO EVIDENT GAPS WERE NOTICED AT THE IMPLANT INTERFACES, BUT LIMITED BONE IN-GROWTH WAS NOTED ON THE POROUS SURFACE OF THE IMPLANTS. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia; Inadequate Osseointegration; Pain

  MAUDE report 14332490 ↗

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)