ATTUNE 1511-10-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295436478), received between Mar 18, 2020 and Apr 30, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL COMPONENTS WERE REMOVED DUE TO INFECTION AND WASH OUT. THERE WAS NO HARM DONE TO THE PT. NOR DELAY TO THE CASE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25042499 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21763327 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL (TKA) TOTAL KNEE ARTHROPLASTY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21154176 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION AND THEY PUT IN A PROSTALAC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16402498 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE REVISION, PATIENT REQUIRED ALL IMPLANTS REMOVED DUE TO INSTABILITY AND INFECTION (NO COLLATERAL LIGAMENTS) FROM REVISION (B)(4), (B)(6) 2020 FROM A POLY EXCHANGE DUE TO INSTABILITY.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available; Unspecified Infection

  MAUDE report 9942980 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION KNEE DUE TO INFECTION. PRIMARY SURGEON PROF. (B)(6). FEMALE PATIENT ID: (B)(6). IMPLANTS STILL IMPLANTED: 1 X 151820038 ATTUNE MEDIAL DOME PAT 38MM - LOT 9268987. 1 X 151314060 ATUNE PRESSFIT STR STEM14X60MM - LOT J1946P. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9847669 ↗