ATTUNE 1518-20-038Recalls & reported problems

Summary

The FDA's MAUDE database contains 393 adverse event reports that list this exact device (DI 10603295056690), received between Jun 29, 2017 and Aug 17, 2026 — classified as 3 deaths, 371 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (32 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 393 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to instability.Affected side: Right Knee.

  Patient problems: Joint Laxity

  MAUDE report 50275577 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient was being revised due to infection.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50208987 ↗
• InjuryJul 29, 2026Loss of or Failure to Bond

  It was reported that patient had aseptic tibial loosening and patellar lysis. All components were revised. Tibia was loose at the tray/cement interface. Femur was not loose. It was stated that tibia and patella were loose. Loosening interface was marked as cement to implant.Affected side-Right knee.

  Patient problems: Osteolysis

  MAUDE report 50072046 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced infection. All components removed. No additional information is availableDOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50042286 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION AFTER INFECTION OF KNEE. THIS REPORT IS RELATED TO COMPLAINTS (B)(4) WHICH CAPTURES PREVIOUS REVISIONS.

  Patient problems: Unspecified Infection

  MAUDE report 25595422 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED; SPACER PLACED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25448507 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REPLACED PATELLA IMPLANT DUE TO ANTERIOR KNEE PAIN/CYSTS. CEMENT MANUFACTURER WAS DEPUY SYNTHES.

  Patient problems: Cyst(s); Pain

  MAUDE report 24936648 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CASE HAD BEEN REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24875190 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SOFT TISSUE LAXITY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24831560 ↗
• InjuryFeb 27, 2026Loss of or Failure to Bond

  HEALTH AUTHORITY REPORT MW5181909 WAS REPORTED TO MANUFACTURER: IT WAS REPORTED THAT ATTUNE RP TIB BASE SZ 4 CEM, ATTUNE MEDIAL DOME PAT 38MM, ATTUNE PS FEM LT SZ 4 CEM, AND UNKNOWN KNEE TIBIAL INSERT WERE ASSOCIATED WITH A REPORTED EVENT. THE PATIENT EXPERIENCED INCREASED SWELLING, PAIN, DECREASED MOBILITY, AND WALKING DIFFICULTY FOLLOWING A TOTAL KNEE REPLACEMENT. IMAGING INDICATED POSSIBLE IMPLANT LOOSENING, AND A REVISION SURGERY WAS PERFORMED WITH A DIAGNOSIS OF FAILED ARTHROPLASTY AND AN OCCULT FRACTURE OF THE ANTERIOR TIBIA. THE TIBIAL INSERT WAS REVISED TO PROVIDE ACCESS TO THE SURGICAL SITE, AND IT WAS NOTED THAT THE LOOSE IMPLANTS MAY HAVE CONTRIBUTED TO THE EVENT DUE TO THEIR BONDING INTERFACE AND RESISTANCE TO LOOSENING. THE IMPLANTS WERE EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 24469106 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2022 DATE OF IMPLANT: (B)(6) 2017 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT TREATMENT/IMPACT: INJECTED MEDICATION: YES.

  Patient problems: Pain

  MAUDE report 24459553 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ATTUNE PRIMARY WAS PUT IN A VALGUS KNEE. TRACKING WELL ON TABLE BUT SUBLUXES WHEN PATIENT FLEXES. LATERAL SIDE AND PATELLA FINE, MEDIAL SIDE - TIBIA MOVES ANTERIOR, FEMUR POSTERIOR. BEARING LOOKS SEATED ON XR, SIZES APPROPRIATE, NO LOOSE BODIES SEEN. IF WENT TO REVISION COULD I USE MEDIAL PIVOT BEARING IN THE PRIMARY TIBIA WITH PS FEMUR. ELDERLY LOW DEMAND PATIENT. NO REVISION SURGERY PLANNED.

  Patient problems: Joint Laxity

  MAUDE report 24443268 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24367041 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24267405 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS SECOND TIME AROUND FOR INFECTION. PARTS WERE REMOVED AND NEW PARTS WERE IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24130071 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098115 ↗
• 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)(6). 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 23810143 ↗
• 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 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 23767614 ↗
• 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 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: (B)(6) 2025. 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 TYP

  Patient problems: Erythema; Pain; Swelling/ Edema

  MAUDE report 23767301 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT TOTAL KNEE DONE ON (B)(6) 2024. THE KNEE BECAME INFECTED AND THE PATIENT WAS BROUGHT IN FOR RESECTION. ALL COMPONENTS WERE REMOVED AND AN ARTICULATING KNEE SPACER WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23454834 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369929 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AND NEEDED IMPLANTS REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23036963 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR PATELLA REVISED FOR ANTERIOR KNEE PAIN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22493131 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22375968 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ORIGINAL TKR WAS A CR ATTUNE IMPLANTED IN 2018. POSTOPERATIVELY, THE PATIENT HAD A LONG SLOW RECOVERY REQUIRING AN MUA TO HELP RANGE. A REVISION WAS PERFORMED IN (B)(6) 2025 WITH A NEW MS POLY REPLACING THE ORIGINAL CR POLY AND PATELLA RESURFACING. A MUA WAS DONE FOR STIFFNESS AT 8 WEEKS POST OPERATIVELY. THERE IS NO PROBLEM WITH THE MS INSERT. THE PATIENT WAS REPORTING IMPROVED STABILITY AND FUNCTION POST REVISION.

  Patient problems: Muscular Rigidity

  MAUDE report 22196367 ↗