ATTUNE 1517-10-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295056126), received between Jan 23, 2019 and Mar 5, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24519540 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ARTERITIS STADE 4 + INFECTION OF LEFT TKA. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 16 JUL 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED): YES; WAS THE SUBJECT READMITTED TO HOSPITAL: YES (READMISSION ON (B)(6) 2025); INJECTED MEDICATION: YES; ORAL MEDICATION: YES; COMPONENTS REMOVED (FEMORAL COMPONENT, FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440107. LOT NUMBER: JG6793. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED LEFT SIZE 7. CATALOG NUMBER: 150660005. LOT NUMBER: 3733875. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION ROTATING PLATFORM TIBIAL BASE CEMENTED SIZE 5. CATALOG NUMBER: 151710706. LOT NUMBER: 9898466. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS ROTATING PLATFORM INSERT AOX SIZE 7 6MM. CONCOMITANT PRODUCTS: CATALOG NUMBER: 66017750. LOT NUMBER: 61441

  Patient problems: Arthritis; Unspecified Infection

  MAUDE report 24024782 ↗
• InjuryOct 23, 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 POST-OPERATIVE ANEMIA DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 15 FEB 2020 DATE OF IMPLANT: (B)(6) 202014 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368131 ↗
• InjuryOct 22, 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 INFECTION OF LEFT TKA. DEVICE RELATED: DEFINITELY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 13 MAY 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE, READMITTED TO HOSPITAL (B)(6) 2025, DIAGNOSTIC INTERVENTION. TREATMENT/IMPACT: STOPPING ANTIBIOTICS AND DECISION TO FOLLOW UP WITH A FISTULISATION

  Patient problems: Unspecified Infection

  MAUDE report 23357305 ↗
• InjuryJul 2, 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 PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22387117 ↗
• InjuryMay 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). EVENT DETAILS: CLINICAL ADVERSE EVENT RECEIVED FOR RELAPSE OR NEW INFECTION OF LEFT TKP. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE: DEFINITELY. PROCEDURE: POSSIBLY. DATE OF EVENT: 17 APR 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION (INITIAL OR PROLONGED), INJECTED MEDICATION AND DIAGNOSTIC INTERVENTION DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440107. LOT NUMBER: JG6793. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: UDI: (B)(4). CATALOG NUMBER:150660005. LOT NUMBER: 3733875. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: UDI: (B)(4). CATALOG NUMBER: 151710706. LOT NUMBER: 9898466. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPTION: UDI: (B)(4). CATALOG NUMBER: 66017750. LOT NUMBER: 61441115. COMPONENT TYPE: CEMENT. DESCRIPTION: UDI: (B)(4).

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22041083 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE EVENT DESCRIPTION TO CAPTURE TREATMENT/IMPACT: TREATMENT/IMPACT: REQUIRES HOSPITALIZATION, IRRIGATION & DEBRIDEMENT, AND ORAL MEDICATION.

  Patient problems: Unspecified Infection

  MAUDE report 20168969 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT: ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO PAIN, AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (REPORTED ON (B)(4) AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021 DOR: (B)(6); (B)(4). AFFECTED SIDE: RIGHT KNEE. (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19323086 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18685776 ↗
• InjuryNov 27, 2023Adverse 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 KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020; DATE OF EVENT: 16 MAY 2021. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, DIAGNOSTIC INVENTION.

  Patient problems: Pain

  MAUDE report 18209063 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP FOR THICKER POLY. NO INFECTION, PATIENT PREFERENCE. NO OTHER INFO KNOWN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2021. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18049192 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO AN INFECTION, A POLY EXCHANGE WAS COMPLETED. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17378033 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI-UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17324224 ↗
• InjuryOct 20, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE DISLOCATED SO A THICKER POLY WAS PLACED. NO ADDITIONAL INFORMATION WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15638424 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14841981 ↗
• InjuryJan 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO DISLOCATED INSERT. SURGEON LEFT ALL COMPONENTS BUT CHANGED OUT THE POLY AND UPSIZED IT. DOI: (B)(6) 2021; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 13288902 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED ON (B)(6) 2021 SECONDARY TO PAIN AND DISCOMFORT OF THE KNEE. SURGEON DETERMINED PAIN WAS CAUSED BY SOFT TISSUE STRETCHING THAT OCCURRED OVER TIME. ZIMMER IMPLANTS WERE EXPLANTED AND ATTUNE CRS CONSTRUCT WAS IMPLANTED. THE PATELLA, FEMORAL COMPONENT, AND TIBIAL COMPONENTS WERE LEFT IN SITU. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Discomfort; Joint Laxity; Pain

  MAUDE report 13075666 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT KNEE). TREATMENT: IV ANTIBIOTICS, SURGICAL I&D WITH REVISION OF ALL FEMORAL CONSTRUCT, TIBIAL CONSTRUCT, INSERT COMPONENTS ON (B)(6) 2018.

  Patient problems: Unspecified Infection

  MAUDE report 12704469 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION (B)(6) 2021. B. LOT NUMBER: ATTUNE CRS FEMORAL RT SZ 7 CEM (150440207) - LOT # J8602J. ATUNE PRESSFIT STR STEM24X60MM (151324060) - LOT # J06R66. REFER TO ADDITIONAL EVENT INFORMATION A-6001132 WHICH HAS THE USAGE FROM THE PRIMARY SURGERY. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. UNKNOWN. D. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12261630 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-03 . CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC JOINT INFECTION, RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: SURGICAL I&D WASHOUT WITH REVISION OF TIBIAL INSERT ON (B)(6) 2021. PRODUCT DETAILS: COMPONENT TYPE: ATTUNE REVISION CRS FEMORAL SIZE 7 RIGHT CEMENTED; CATALOG NUMBER: 150440207; LOT NUMBER: J7266U. COMPONENT TYPE: ATTUNE REVISION CEMENTED STEM 14 MM X 30 MM; CATALOG NUMBER: 151214030; LOT NUMBER: J8376X. COMPONENT TYPE: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 5 CEMENTED; CATALOG NUMBER: 150660005; LOT NUMBER: 9572262. COMPONENT TYPE: TIBIAL STEM - ATTUNE REVISION PRESSFIT STEM 10 MM X 60 MM; CATALOG NUMBER: 151310060; LOT NUMBER: J55J71. COMPONENT TYPE: ATTUNE REVISION TIBIAL SLEEVE POROCOAT FULLY COATED 37 MM; CATALOG NUMBER: 151111202; LOT NUMBER: J7205T. COMPONENT TYPE: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 7 6 MM; CATALOG NUMBER: 151710706; LOT NUMBER: 9334375. COMPETITOR (ZIMMER) BONE CEMENT UTIL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12099772 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PATELLA PAIN AND SLIGHT MALTRACKING. PATIENT WAS BROUGHT TO OR FOR PATELLA RESURFACING. SURGEON HAD CHOSEN NOT TO RESURFACE AT TIME OF INDEX PROCEDURE DUE TO HOW THIN THE PATELLA WAS. PATELLA RESURFACING PERFORMED UNEVENTFULLY IN CONJUNCTION WITH A LATERAL RELEASE. SURGEON NOTICED SOME LAXITY IN THE KNEE AND DECIDED TO TRIAL A THICKER INSERT. A THICKER INSERT WAS FOUND TO BE MORE STABLE AND THE INSERT WAS EXCHANGED. THIS KNEE IS WELL ALIGNED AND SIZED, NO POLY WEAR WAS NOTED, NOR WAS IT PUT IN WITH ANATOMIC ALIGNMENT TECHNIQUE. IT WAS SIMPLY LOOSER THAN HE FELT WAS APPROPRIATE. DEPUY CEMENT WAS USED IN THIS KNEE REPLACEMENT BUT IT IS HOSPITAL OWNED AND NOT IN RECORDS. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11891701 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY WAS REMOVED. NO LOOSE COMPONENTS REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11832165 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT KNEE WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS FOR A WASH OUT. NO LOOSENING AND NO DELAY IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11712872 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11466575 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LEFT ATTUNE REVISION KNEE PATIENT, WASHOUT AND EXCHANGE OF INSERT LINER. ORIGINAL SURGERY ON THE (B)(6) 2020 BY SAME SURGEON AT FLINDERS PRIVATE. LARGE HEMATOMA FOUND ON OPENING OF PREVIOUS WOUND, MULTIPLE SPECIMENS TAKEN TO SEE IF INFECTION IS ALSO A CAUSE OF ALL THE SWELLING WITHIN THE KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Hematoma; Swelling/ Edema

  MAUDE report 11089010 ↗