ATTUNE 1516-30-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295048138), received between Oct 25, 2017 and Mar 10, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT WITH POLY SWAP FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24557442 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THE POLY HAD TO BE SWAPPED DUE TO AN INFECTION. NO SURGICAL DELAY. NO ADVERSE SIDE EFFECTS.

  Patient problems: Unspecified Infection

  MAUDE report 19782153 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR BAKER'S CYST. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: (B)(6) 2013 (LEFT KNEE). TREATMENT: US GUIDED ASPIRATION AND STEROID INJECTION.

  Patient problems: Cyst(s)

  MAUDE report 18141161 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. A POLY SWAP AND IRRIGATION AND DEBRIDEMENT (I&D) WAS NEEDED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17557815 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2022; DATE OF REVISION: (B)(6) 2023; (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 16993531 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A LOOSE IN FLEXION AND EXTENSION. CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14753391 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INFECTION. A BILATERAL KNEE WAS REVISED. DID I&D/POLY SWAP OF BOTH KNEES. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE. CAPTURES THE IMPLANT: ATTUNE CR RP INSRT SZ 8 8MM (151630808/9166184).

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

  MAUDE report 12441106 ↗
• InjurySep 1, 2021Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT PATIENT WAS IN THE PROCESS OF SITTING DOWN WHEN THEY HEARD A LARGE POP AND AT THE SAME TIME RIPPED OPEN PATIENT INCISION SITE. BROUGHT TO THE OR AND FOUND PATELLA TENDON WAS TORN. REPAIRED TENDON, EXCHANGED POLY AND WASHED OUT KNEE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Muscle/Tendon Damage; Wound Dehiscence

  MAUDE report 12408155 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, ARTHROFIBROSIS, STIFFNESS, LAXITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED OSTEOLYSIS BENEATH THE TIBIAL TRAY AND DEBRIDING SIGNIFICANT SCAR TISSUE IN THE KNEE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Osteolysis; Pain

  MAUDE report 11603293 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED AN 8 MM POLY AND REPLACED WITH A 10 MM POLY TO HELP MAKE THE PATIENT KNEE MORE STABLE. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9224482 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON WENT IN AND FOUND ALL THE COMPONENTS WELL FIXED AND POSITIONED. HE ENDED UP CHANGING THE INSERT TO ONE SIZE THICKER. ALL THE OTHER COMPONENTS WERE RETAINED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7313632 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6977274 ↗