ENGAGERecalls & reported problems across all models
Smith & Nephew, Inc. · 80 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one ENGAGE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 97
- Deaths reported
- 0
- Injuries reported
- 91
- Recalls
- 4
We found 80 models of ENGAGE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2022 and Apr 29, 2025 — classified as 91 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (16 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ENGAGE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1673-2023 · Root cause: Under Investigation by firm · names 48 of these models · Recall details · FDA record ↗
- 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 · names 12 of these models · Recall details · FDA record ↗
- 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-1671-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- 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-1670-2023 · Root cause: Under Investigation by firm · names 14 of these models · Recall details · FDA record ↗
Most reported ENGAGE problems
Device problems
- Adverse Event Without Identified Device or Use Problem48
- Failure to Osseointegrate16
- Fracture7
- Malposition of Device5
- Positioning Problem5
- Loosening of Implant Not Related to Bone-Ingrowth4
- Migration4
- Loss of Osseointegration3
Patient problems
- Pain51
- Inadequate Osseointegration22
- Arthralgia19
- Failure of Implant18
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions9
- Deformity/ Disfigurement7
- Discomfort6
ENGAGE models
80 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENGAGE 1-10003-410Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall10 reports
- ENGAGE 1-10011-300PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
- ENGAGE 1-10012-500Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall6 reports
- ENGAGE 1-10003-510PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall5 reports
- ENGAGE 1-10012-550PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall5 reports
- ENGAGE 1-10003-600Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall4 reports
- ENGAGE 1-10012-450PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
- ENGAGE 1-10003-500Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall3 reports
- ENGAGE 1-10003-610PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall3 reports
- ENGAGE 1-10011-200Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall3 reports
- ENGAGE 1-10012-350Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall3 reports
- ENGAGE 1-10013-509PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall3 reports
- ENGAGE 1-10003-200Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall2 reports
- ENGAGE 1-10003-310Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall2 reports
- ENGAGE 1-10011-100PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall2 reports
- ENGAGE 1-10012-200Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall2 reports
- ENGAGE 1-10012-300PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall2 reports
- ENGAGE 1-10012-400Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall2 reports
- ENGAGE 1-10012-600Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall2 reports
- ENGAGE 1-10013-609PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall2 reports
- ENGAGE 1-10003-210PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10003-300PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10003-710PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10012-250PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10013-261PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10013-359PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10013-410Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall1 report
- ENGAGE 1-10013-559Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall1 report
- ENGAGE 1-10013-560PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- ENGAGE 1-10013-660Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall1 report
- ENGAGE 1-10003-100PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10003-110Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10003-700Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10012-100Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10012-150PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10012-650PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-109Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-110PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-111PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-113Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-159Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-160PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-161Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-163Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-209Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-210PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-211PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-213Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-259Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-260PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-263PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-309Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-310Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-311Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-313PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-360PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-361Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-363PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-409PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-411Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-413Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-459Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-460Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-461PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-463Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-510Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-511PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-513Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-561Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-563Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-610Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-611Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-613Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-659Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall0 reports
- ENGAGE 1-10013-661PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-10013-663PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ENGAGE 1-50085-000Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer7 reports
- ENGAGE 1-50042-109Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 report
- ENGAGE 1-50080-001Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 report
Recent ENGAGE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A CONVERSION OF AN ENGAGE UNI TO A TKA SURGERY, IT WAS NOTICED THAT THE HOOK OF ONE (1) ANCHOR REMOVAL TOOL WAS BROKEN OFF. THE PROCEDURE WAS PERFORMED, AFTER SIGNIFICANT DELAY, WITH A DIFFERENT SURGICAL TECHNIQUE, SINCE THE TEAM HAD TO BURR AWAY THE BONE AROUND THE ANCHOR AND PRY THE WHOLE TIBIA OFF WHILE IT WAS STILL ATTACHED TO THE ANCHOR. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928035 ↗MalfunctionApr 24, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A CONVERSION OF AN ENGAGE UNI TO A TKA SURGERY, THE THREADS OF ONE (1) ANCHOR REMOVAL GUIDE SZ 1-3 LEFT MED DID NOT ENGAGE INTO THE FRONT OF THE BASEPLATE. UPON COMPARING IT TO ANOTHER ANCHOR REMOVAL GUIDE, IT WAS NOTICED THE THREADS HAD BEEN AMPUTATED AND WERE NOT LONG ENOUGH TO THREAD INTO BASEPLATE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SIGNIFICANT DELAY AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21901388 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER PKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ENGAGE POROUS TIBIAL TRAY SZ 5 LT MED FAILURE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ALL COMPONENTS WERE REMOVED AND CONVERTED TO A TOTAL KNEE ARTHROPLASTY. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21543048 ↗InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A LEFT MEDIAL UKR ON (B)(6) 2022 BECAUSE THE PATIENT SUFFERED AN INTRACTABLE ARTHRITIC KNEE PAIN WHICH HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT. IN ADDITION, PATIENT ALSO HAS EXPERIENCED RIGHT KNEE PAIN. AN ENGAGE PARTIAL KNEE SYSTEM WAS IMPLANTED AND THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RETURNED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. FURTHERMORE, ON (B)(6) 2023 PATIENT UNDERWENT ARTHROCENTESIS/ASPIRATION FOLLOWED BY AN INJECTION OF EUFLEXXA. ADDITIONALLY, ON (B)(6) 2023 BONE SCAN SEEMS POSITIVE ON ALL THREE PHASES FOR ASYMMETRIC RADIOTRACER ACCUMULATION ADJACENT TO THE TIBIAL COMPONENT OF THE PATIENT'S MEDIAL UNICOMPARTMENTAL ARTHROSCOPY, MOST SUGGESTIVE OF HARDWARE LOOSENING (ASEPTIC VERSUS SEPTIC). THE SYSTEM WAS RECALLED AND THE PATIENT IS HAVING UNSPECIFIED ISSUES AND TO DATE IT IS UNKNOWN IF THE WHETHER CLAIMANT HAS BEEN REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Pain
MAUDE report 21060221 ↗MalfunctionDec 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING PROCEDURE, THE INSERT TRIAL SZ 1 LEFT MED 9MM BROKE. PARTS WERE ALL RETRIEVED. SURGERY WAS PERFORMED, WITH THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819815 ↗InjuryAug 12, 2024Osseointegration 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 TIBIA LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 19967115 ↗InjuryAug 6, 2024Adverse 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, THE PATIENT EXPERIENCED AN USPECIFIED FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023. CURRENT HEALTH STATUS OF PATIENT IN UNKNOWN.
Patient problems: Bone Fracture(s)
MAUDE report 19919034 ↗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 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 ↗InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS THAT, AFTER A UKA HAD BEEN PERFORMED ON (B)(4) 2023, THE PATIENT UNDERWENT A REVISION SURGERY TO A TKA ON (B)(4) 2023, DUE TO THE ENGAGE POROUS TIBIAL TRAY SZ 4-RT MED NOT BEING INGROWN AND HAD STARTUP PAIN. IN ADDITION, ONE (1) ENGAGE TIBIAL INSERT SZ 4-RT MED 9MM, ONE (1) ENGAGE POROUS FEMORAL SZ 5-RT MED AND ONE (1) ENGAGE POROUS FEMORAL SZ 5-RT MED WERE REMOVED.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 18359968 ↗InjuryOct 16, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER A KNEE SURGERY HAD BEEN PERFORMED A YEAR AGO, THE PATIENT EXPERIENCED PAIN. IMAGES WERE TAKEN AND IT WAS FOUND THAT THE ENGAGE TIBIAL ANCHOR STEM SZ 3-4 FRACTURED AND THE ENGAGE POROUS TIBIAL TRAY SZ 4-LT MED SUBSIDED. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) SEP, IN WHICH THE COMPONENTS WERE REMOVED AND A PRIMARY KNEE WAS IMPLANTED WITH TJO. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF PATIENT.
Patient problems: Failure of Implant; Pain
MAUDE report 17939800 ↗InjurySep 5, 2023Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED EXTREME PAIN, INFECTION, LOOSENING AND MECHANICAL FAILURE. A REVISION SURGERY WAS WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. THE FOLLOWING FOUR IMPLANTS WERE EXPLANTED: ENGAGE POROUS FEMORAL SZ 7-LT MED, ENGAGE TIBIAL INSERT SZ 6-LT MED 9MM, ENGAGE POROUS TIBIAL TRAY SZ 6-LT MED AND ENGAGE TIBIAL ANCHOR STEM SZ 5-6.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 17686763 ↗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 ↗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 ↗InjuryAug 14, 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) 2022 WITH AN ENGAGE SYSTEM, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH CONVERSION TO TKA WAS CONDUCTED BY PLACING A JOURNEY II CONSTRUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Pain
MAUDE report 17540978 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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