ATTUNE 1504-10-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10603295041634), received between Oct 6, 2017 and Sep 22, 2026 — classified as 112 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a Revision of an Attune PSRP construct was done due to patella and femoral component loosening. Tibia was well fixed, but was explanted. No allegation made against the poly. Bone scans showed a ¿hot¿ patella and femoral component indicating loosening. The patient had struggled with the knee from the beginning, and then started regressing. Their leg was very stiff and had poor ROM. All components were removed and Attune Revision was implanted. Surgeon uses CMW2 cement. Suspected cement-bone interface as components came out with cement on them. Side Affected: Left Side.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 50858165 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUBLUXED THEIR TOTAL KNEE COMPONENT. THEY WERE REVISED DUE TO THAT INSTABILITY. THE ATTUNE PS FEMORAL COMPONENT WAS REMOVED AND CHANGED TO AN ATTUNE REVISION FEMORAL COMPONENT AND THE BEARING WAS ALSO CHANGED TO A REVISION CRS BEARING. THE TIBIA AND PATELLA WERE LEFT IN PLACE AND NOT REVISED. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 24333850 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. STAGE 1 REMOVAL OF ALL 3 IMPLANTS. NATIVE PATELLA. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24244935 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND SURGEON SUSPICION OF INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 24221373 ↗
• InjuryDec 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE, LOOSENING OF TIBIA AND LOOSENING OF FEMUR WAS REPORTED AT UNKNOWN INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23876382 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR BILATERAL LEG CELLULITIS - WORSE ON LEFT LEG DEVICE AND PROCEDURE (RELATEDNESS) , DEVICE RELATED: DEFINITELY NOT , PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29 OCT 2025, DATE OF IMPLANT: (B)(6) 2024, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: OUTCOME: ONGOING.

  Patient problems: Cellulitis

  MAUDE report 23810148 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT STUDY KNEE DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: PROBABLY TREATMENT/IMPACT: READMISSION ((B)(6) 2025); ARTHROSCOPY DATE OF EVENT: 29 OCT 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; INJECTED MEDICATION: YES TREATMENT/IMPACT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: TRUE DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106 LOT NUMBER: 4315735 COMPONENT TYPE: FEMORAL COMPONENT DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM CATALOG NUMBER: 150660005 LOT NUMBER: 3733874 COMPONENT TYPE: TIBIAL BASE COMPONENT DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED CATALOG NUMBER: 151650612 LOT NUMBER: 9493237 COMPONENT TYPE: TIBIAL INSERT COMPONENT DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM CATALOG NUMBER: 151820038 LOT NUMBER: 4304615 COMPONENT TYPE: PATELLA DESCRIPTION: ATTUNE MEDIAL DOME PAT 38MM CATALOG NUMBER: 66017569 LOT NUMBER: 67681283 COMPONENT TYPE: CEMENT DESCRIPTION: PALACOS R+G 2X40.

  Patient problems: Unspecified Infection

  MAUDE report 23767451 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 OCT 2025. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INJECTED MEDICATION. CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, REDNESS AND SWELLING IN STUDY KNEE. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. TREATMENT: HOSPITALIZATION (INITIAL OR PROLONGED): YES, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: YES, READMISSION: UN (B)(6) 2025. DEPUY SYNTHES PRODUCTS USED: DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410106, LOT NUMBER: 4315735, COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: ATTUNE P/S FEM LT SZ 6 CEM. CATALOG NUMBER: 15066000, LOT NUMBER: 3733874., COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED. CATALOG NUMBER: 151650612, LOT NUMBER: 9493237, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPTION: ATTUNE PS RP INSRT SZ 6 12MM. CATALOG NUMBER: 151820038, LO

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 23767098 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY AND CHOSE NOT TO TRIAL A DIFFERENT SIZE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23631556 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23544888 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE IN 2022. CUSTOMER WAS NOT ABLE TO FIND THE EXACT DATE IN 2022 ON WHICH THE SURGERY WAS PERFORMED. PATIENT PRESENTED WITH INFECTED TOTAL KNEE. SURGEON REMOVED THE TOTAL KNEE AND REPLACED WITH ANTIBIOTIC IMPREGNATED SURESPACE CEMENT SPACER. PATELLA WAS LEFT IN PLACE. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22924116 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A TKA SURGERY FOR OA ON KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, IN (B)(6) 2025, THE PATIENT HAD PAIN AND AN INFECTION WAS DISCOVERED. THE REMOVAL SURGERY IS SCHEDULED ON (B)(6).

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22394987 ↗
• MalfunctionJun 18, 2025Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE FEMUR IMPLANT WRAP CAME WITH A HOLE. ALTHOUGH THE OUTER WRAPPER WAS INTACT WITH THE UNSCATHED PLASTIC SEAL, WHEN IMPLANT WAS OPENED AND DELIVERED IT WAS NOTICED THAT THE FIRST WRAPPER (SECOND PACKAGING) HAD A HOLE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282423 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FROM PRIMARY ATTUNE TO ATTUNE REVISION. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 22004237 ↗
• InjuryApr 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS PATIENT WAS BEING REVISED TO DUE PAIN AND SUSPECTED LOOSE COMPONENTS AT CEMENT TO IMPLANT INTERFACE. DURING THIS CASE AN ATTUNE PS FEMORAL COMPONENT, RP TIBIAL BASEPLATE AND PS RP BEARING WERE REMOVED. THE PATELLA COMPONENT WAS LEFT IN PLACE. THE SURGEON PROCEEDED TO PREP AND IMPLANT ATTUNE REVISION COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21741371 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED PATELLA, SEVERE FLEXION CONTRACTURE, AND FLEXION/EXTENSION MISMATCH. JOINT WAS EXPLANTED. TEMPORARY SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture; Joint Dislocation; Joint Laxity

  MAUDE report 21571401 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO POSTTRAUMATIC OSTEOARTHRITIS WITH MILD TO MODERATE VALGUS DEFORMITY AND MILD HYPEREXTENSION OF THE LEFT KNEE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR¿S BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND JOINT INSTABILITY. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS EASILY REMOVED AS IT HAD COMPLETELY DISLOCATED FROM THE CEMENT MANTLE. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH LITTLE BONE LOSS WITH HAND TOOLS AND OSTEOTOMES. THE SURGEON REPORTED THE PATELLA WAS INTACT AND WELL-FIXED AND WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (LEFT KNEE).

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 20655519 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPLANT DECELLEMENT. ADDITIONAL EVENT INFORMATION: INITIAL INVESTIGATION IS BEING CONDUCTED TO DETERMINE WHAT REPORTER MEANT BY IMPLANT DECELLEMENT.

  Patient problems: Pain

  MAUDE report 20348090 ↗
• MalfunctionMay 8, 2024Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED AS NORMAL WITH NO GLITCHES, HOWEVER WHEN COMING TO SEAT THE FINAL IMPLANT, IT WOULD NOT SIT FLUSH TO THE BONE. THERE WAS A LARGE GAP OF AROUND 0.5MM ON BOTH SIDES. ACCORDING TO THE SURGEON HE FELT THE LUGS WERE NOT GOING SITTING IN THE LUG HOLES CORRECTLY. THE LUG HOLES HAD DEFINITELY BEEN DRILLED PRIOR TO IMPLANTATION, AND WERE ALSO RE-DRILLED FREE HAND WHEN IT FAILED, BUT THIS DIDN'T HELP AND WE STILL COULDN'T SIT THE IMPLANT. SURGEON HAD TO IMPLANT THE TIBIA WITH THE FEMORAL TRIAL AND TRIAL INSERT INSTEAD. NEW CEMENT MIX REQUIRED. WE OPENED A SECOND FEMUR TO COMPARE TO THE 'FAULTY ONE'. THE SURGEON THINKS ONE OF THE LUGS MAY BE SLIGHTLY OFF-CENTRE, HENCE THE DIFFICULTIES IMPLANTING. NO OVERLY HEAVY IMPACTION NOTICED WHEN TRYING TO IMPACT THE FAULTY FEMUR. SURGERY WAS PROLONGED 15 MINUTES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268465 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR LOSS OF FLEXION TO STUDY LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: 04 MAR 2024 (LEFT KNEE) TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 19187661 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND SEPTIC LOOSENING OF THE FEMUR AND TIBIAL COMPONENT AT THE BONE/CEMENT INTERFACE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19106523 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR TORN PATELLA TENDON. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). ADDITIONAL EVENT INFORMATION: TREATMENT: IT WAS REPORTED BY THE CLINICAL SITE THAT THE PATIENT RECEIVED AS TREATMENT AN UNSPECIFIED INJECTED MEDICATION, HOSPITALIZATION WITH A SURGICAL IRRIGATION & DEBRIDEMENT, AND A SURGICAL REPAIR OF THE PATELLAR TENDON.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18906236 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO SURGICAL DELAY.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18807197 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY WITH A FEMORAL AUTOLOGOUS BONE GRAFTING ON (B)(6) 2017 TO ADDRESS PAIN, AND PSORIATIC ARTHRITIS. ON 06 MAR 2023, LEFT KNEE WAS REVISED TO ADDRESS PAIN, RECURRENT PATIENT FALLS AND LEFT KNEE INSTABILITY, WITH REPLACEMENT OF TIBIAL AND FEMORAL COMPONENTS TO COMPETITOR SYSTEM. THE PRIMARY PATELLA COMPONENT TRACKED WELL AND WAS RETAINED. DOI: (B)(6) 2017. DOR: MAR 06, 2023. LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 18543740 ↗
• InjuryJan 4, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6); STUDY ID: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2017; DATE OF REVISION: (B)(6) 2023; (LEFT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18442493 ↗