SMARTSETRecalls & reported problems across all models
Depuy (Ireland) · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,415
- Deaths reported
- 2
- Injuries reported
- 4,159
- Recalls
- 0
We found 7 models of SMARTSET by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 4,415 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and Sep 21, 2026 — classified as 2 deaths, 4,159 injuries, 254 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (3,342 reports).
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
Most reported SMARTSET problems
Device problems
- Loss of or Failure to Bond3,342
- Adverse Event Without Identified Device or Use Problem599
- Loose or Intermittent Connection163
- Loosening of Implant Not Related to Bone-Ingrowth161
- Chemical Problem107
- Insufficient Device Problem Information74
- Loss of Osseointegration70
- Failure To Adhere Or Bond34
Patient problems
- No Code Available2,561
- Pain2,410
- Adhesion(s)537
- Insufficient Information379
- Edema377
- Not Applicable273
- Unspecified Infection240
- Joint Laxity214
SMARTSET models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SMARTSET 5450-50-501BONE CEMENT, ANTIBIOTIC1,690 reports
- SMARTSET 5450-35-500MIXER, CEMENT, FOR CLINICAL USE2 deaths965 reports
- SMARTSET 3122-040BONE CEMENT824 reports
- SMARTSET 3092-040BONE CEMENT, ANTIBIOTIC821 reports
- SMARTSET 3102-080DISPENSER, CEMENT75 reports
- SMARTSET 3092-020BONE CEMENT, ANTIBIOTIC23 reports
- SMARTSET 3122-020BONE CEMENT17 reports
Recent SMARTSET adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Laxity
MAUDE report 50847271 ↗MalfunctionSep 18, 2026Device Damaged Prior to Receipt by User
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823371 ↗InjurySep 11, 2026Loss of or Failure to Bond
It was reported that patient had aseptic tibial loosening. Tibia loosened at the tray/cement interface. All components were removed and revision components placed. There was no delays or patient injury.DOI: (b)(6) 2012,DOR: (b)(6) 2026,Affected side: Left Knee.
Patient problems: Insufficient Information
MAUDE report 50734468 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to wound never healing. Put in static spacerAffected side: Right knee.
Patient problems: Impaired Healing
MAUDE report 50116074 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient was revised due to wound never healing. Put in static spacer.Affected side: Right knee.
Patient problems: Impaired Healing
MAUDE report 50115861 ↗InjuryJul 30, 2026Loss of or Failure to Bond
It was reported that patient had limited range of motion. Upon revision, the stem was found to be loose in its cement mantle. All components but the metaglene and screws were revised. It was stated that humeral stem was loose. Loosening interface was marked as cement to implant. Cement manufacturer was marked as DePuy Synthes. DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right shoulder.
Patient problems: Loss of Range of Motion
MAUDE report 50091054 ↗InjuryJul 30, 2026Loss of or Failure to Bond
It was reported that patient had limited range of motion. Upon revision, the stem was found to be loose in its cement mantle. All components but the metaglene and screws were revised. It was stated that humeral stem was loose. Loosening interface was marked as cement to implant. Cement manufacturer was marked as DePuy Synthes. DOI: (b)(6) 2026.DOR:(b)(6) 2026.Affected side: Right shoulder.
Patient problems: Loss of Range of Motion
MAUDE report 50091048 ↗InjuryJul 29, 2026Loss of or Failure to Bond
It was reported that the patient experienced aseptic tibial loosening. Tibia loosened at the cement/implant interface. All components were revised. Femur was not loose. No patient injury or delay.DOI: Unknown. DOR: On (b)(6) 2026.Affected side: Right Knee.
Patient problems: Insufficient Information
MAUDE report 50073333 ↗InjuryJun 4, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING AT THE TIBIA CEMENT INTERFACE. DEPUY CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25390669 ↗MalfunctionJun 4, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING AT THE TIBIA CEMENT INTERFACE. DEPUY CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25390666 ↗InjuryMay 18, 2026Loss of or Failure to Bond
IT WAS REPORTED ON 08-28-2017, PATIENT RECEIVED AN ATTUNE LEFT POSTERIOR STABILIZED, FIXED BEARING TOTAL KNEE REPLACEMENT, UTILIZING TRUMATCH TECHNOLOGY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO COMPLICATIONS. DEPUY SMARTSET BONE CEMENT WAS USED. ON (B)(6) 2018, LEFT KNEE WAS REVISED TO ADDRESS LEFT KNEE TIBIAL IMPLANT LOOSENING, AT THE CEMENT TO IMPLANT INTERFACE. INTRAOPERATIVELY, THE FEMUR AND PATELLA WERE FOUND TO BE WELL-FIXED, BUT THE TIBIAL TRAY WAS GROSSLY LOOSE, COMPLETELY DEBONDED FROM THE CEMENT MANTLE, AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE ALL REVISED, AND REPLACED WITH COMPETITOR REVISION COMPONENTS. THE DEPUY ATTUNE PATELLA WAS RETAINED. DOI: ON (B)(6) 2017, DOR: ON (B)(6) 2018 LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 25199813 ↗MalfunctionMay 5, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT HAD ASEPTIC TIBIAL LOOSENING. TIBIAL TRAY DEBONDED AT THE CEMENT/TRAY INTERFACE. FEMUR WASN'T LOOSE. THE TIBIA AND FEMUR WERE BOTH REVISED. NO PATIENT INJURY OR DELAY. NO MORE INFO KNOWN. PRODUCT STATED TO BE LOOSE: TIBIA. LOOSENING INTERFACE: CEMENT TO IMPLANT. CEMENT MANUFACTURER: DEPUY. DOI: (B)(6) 2012. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25085012 ↗InjuryMay 5, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT THE PATIENT HAD ASEPTIC TIBIAL LOOSENING. TIBIAL TRAY DEBONDED AT THE CEMENT/TRAY INTERFACE. FEMUR WASN'T LOOSE. THE TIBIA AND FEMUR WERE BOTH REVISED. NO PATIENT INJURY OR DELAY. NO MORE INFO KNOWN. PRODUCT STATED TO BE LOOSE: TIBIA. LOOSENING INTERFACE: CEMENT TO IMPLANT. CEMENT MANUFACTURER: DEPUY. DOI: (B)(6) 2012, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 25084995 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS COMPLAINING ABOUT LEG GIVING OUT. X-RAY SHOWED A VERY WORN POLY LATERALLY. WHEN THE POLY WAS REMOVED THERE WAS ALSO WEAR ON THE TIBIAL BASEPLATE. A REMOVAL OF ALL IMPLANTS EXCEPT PATELLA OCCURRED. A STEMMED ATTUNE REVISION TIBIA AND FEMUR CONSTRUCT WAS IMPLANTED. THERE WAS SOME WEAR ON THE TIBIAL BASEPLATE AND SCRATCHES ON THE ORIGINAL FEMUR WHERE THE POLY LATERALLY HAD WORN THROUGH. THE SIGMA PATELLA WAS RETAINED. DOI: (B)(6) 2010. DOR: (B)(6), 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Joint Laxity
MAUDE report 24966127 ↗InjuryApr 17, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. TIBIAL IMPLANT WAS POSITIONED WITH A SLIGHT ANTERIOR SLOPE. TIBIA DEBONDED AT THE CEMENT/IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED. FEMUR WAS NOT LOOSE. NO DELAYS OR PT INJURY. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912131 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →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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