SMARTSET 5450-50-501Recalls & reported problems
Depuy (Ireland) · Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g · Class 2 · Implant
All models of SMARTSET (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the DePuy Smartset gentamicin bone cement, used to fix joint implants in place. The 1,686 reports mostly describe the cement failing to bond with the implant, leaving tibial parts loose and needing revision surgery. The records include no deaths, 1,574 injuries and 112 malfunctions, and no recalls name this device. Reports fell to 29 in the last 12 months from 51 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,690
- Deaths reported
- 0
- Injuries reported
- 1,578
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,690 adverse event reports that list this exact device (DI 10603295174295), received between Jun 28, 2017 and Sep 21, 2026 — classified as 1,578 injuries, 112 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1,275 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, 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.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond1,275
- Adverse Event Without Identified Device or Use Problem210
- Loose or Intermittent Connection73
- Chemical Problem68
- Loosening of Implant Not Related to Bone-Ingrowth58
- Insufficient Device Problem Information46
- Loss of Osseointegration24
- Failure To Adhere Or Bond15
Patient problems
- No Code Available941
- Pain806
- Insufficient Information235
- Adhesion(s)158
- Edema116
- Not Applicable103
- Unspecified Infection91
- Synovitis80
Recent adverse event reports
The 25 most recent of 1,690 reports, 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 ↗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 ↗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 ↗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 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 ↗InjuryApr 7, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT¿S TIBIAL TRAY HAD COLLAPSED INTO VARUS. WHEN THE TRAY WAS REMOVED, THE UNDERSIDE HAD LOOSENED FROM THE CEMENT. THE FEMORAL IMPLANT WAS ALSO REMOVED; THERE WAS NO FEMORAL LOOSENING. IT WAS STATED THAT TIBIAL TRAY WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. DOI: (B)(6) 2015. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 24800270 ↗InjuryApr 3, 2026Loss of or Failure to Bond
IT WAS REPORTED THERE WAS FEMORAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Insufficient Information
MAUDE report 24778696 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24607235 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24607233 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24607232 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24530443 ↗InjuryFeb 24, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 24433098 ↗InjuryFeb 24, 2026Loss of or Failure to Bond
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 24433087 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
MEDICAL RECORDS REVIEW ((B)(4) MEDICAL RECORDS AD (B)(6) 2026): ON (B)(6) 2022, PATIENT WAS SEEN IN PHYSICIAN'S OFFICE TO ADDRESS SEVERE PAIN, DISCOMFORT AND INSTABILITY IN HIS LEFT KNEE. THE LEFT KNEE WAS AN ATTUNE TOTAL KNEE ARTHROPLASTY. RADIOGRAPHS AP LATERAL MERCHANT ROSENBERG VIEWS OF THE LEFT KNEE DEMONSTRATED INCREASED LUCENCY SURROUNDING THE TIBIA AND SUBTLE LUCENCY SURROUNDING THE TIBIAL KEEL IN THE LATERAL VIEW. THE FEMORAL COMPONENT DEMONSTRATED MILD LUCENCY SURROUNDING THE ANTERIOR FLANGE. IMPRESSION: CEMENTED LEFT TOTAL KNEE ARTHROPLASTY POSTERIOR STABILIZED ROTATING PLATFORM IMPLANTS WITH CONCERN FOR TIBIAL LUCENCY, POSSIBLE FEMORAL LUCENCY AS WELL. PHYSICAL EXAM: THE LEFT KNEE SHOWS A WELL-HEALED MIDLINE INCISION WITH NO OBVIOUS EFFUSION BUT THERE IS TENDERNESS ON THE TIBIA THAT RADIATES UP THE THIGH. HE HAS DIFFICULTY AMBULATING AND HE IS LIMPING, USING A WALKER AND STATES THAT IS BECAUSE OF HIS LEFT KNEE PAIN HIS TOES ARE WARM PINK AND PERFUSED AND HIS PERONEAL NERVE IS INTACT. THE KNEE DEMONSTRATES NO SIGNIFICANT LAXITY WITH VARUS AND VALGUS STRESS TESTING. ASSESSMENT: 1. STABLE COMPETITOR BRAND RIGHT TOTAL KNEE WITH GOOD OUTCOMES. 2. PAINFUL LEFT TOTAL KNEE WITH
Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Osteolysis; Pain; Swelling/ Edema
MAUDE report 24421750 ↗InjuryJan 30, 2026Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO LOOSE TIBIA AT THE IMPLANT CEMENT INTERFACE. DOI- (B)(6) 2014. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 24225333 ↗InjuryJan 30, 2026Loss of or Failure to Bond
PATIENT WAS REVISED DUE TO LOOSE TIBIA AT THE IMPLANT CEMENT INTERFACE. DOI: ON (B)(6) 2014, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.
Patient problems: Insufficient Information
MAUDE report 24225325 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SECOND LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 24210630 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6), STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).
Patient problems: Unspecified Infection
MAUDE report 24200722 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).
Patient problems: Unspecified Infection
MAUDE report 24200714 ↗
Other BONE CEMENT, ANTIBIOTIC devices
- SMARTSET 3092-040Depuy (Ireland) · BONE CEMENT, ANTIBIOTIC821 reports
- Simplex HV with Gentamicin 6195-1-001OSARTIS GmbH · Bone Cement, Antibiotic1 recall64 reports
- PALACOS® MV+G pro 40Heraeus Medical GmbH · Bone Cement, Antibiotic2 recalls0 reports
- PALACOS® R+G pro 40Heraeus Medical GmbH · Bone Cement, Antibiotic2 recalls0 reports
- PALACOS® MV+G pro 80Heraeus Medical GmbH · Bone Cement, Antibiotic2 recalls0 reports
- PALACOS® R+G pro 80Heraeus Medical GmbH · Bone Cement, Antibiotic2 recalls0 reports
- Refobacin® Bone Cement R 110034355Biomet · BONE CEMENT, ANTIBIOTIC79 reports
- SMARTSET 3092-020Depuy (Ireland) · BONE CEMENT, ANTIBIOTIC23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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