ATTUNE 1516-20-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295045410), received between Apr 29, 2020 and Aug 11, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT NOT MUCH INFORMATION AVAILABLE YET, BUT IT WAS NOTED THAT THE PATIENT HAD A DISLOCATION THE DAY AFTER SURGERY. THE IMPLANT COMPONENTS HAVE NOT SHIFTED AT ALL (I.E. FEMUR, TIBIA AND PATELLA ARE STILL PROPERLY CEMENTED IN PLACE AND THE INSERT IS STILL FULLY SEATED ON THE TIBIAL COMPONENT AS IT SHOULD BE), BUT THAT THE PATIENT¿S FEMUR HAD MOVED ANTERIORLY COMPARED TO THE TIBIA SO THAT THE FEMUR AND TIBIA WERE NO LONGER ALIGNED. FROM DISCUSSION WITH ONE OF THE SURGEONS, THE CAUSE IS NOT YET KNOWN AND FURTHER INVESTIGATIONS ARE ONGOING.

  Patient problems: Joint Dislocation

  MAUDE report 22771629 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. HER PRIMARY ATTUNE 6MM FIXED BEARING CRUCIATE TIBIAL INSERT WAS REMOVED AND REPLACED BY AN ATTUNE 10MM FIXED BEARING MEDIAL STABILIZED TIBIAL INSERT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18640176 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT "ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL REVISION SURGERY IN (B)(6) DR. LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL) REVISION ON LEFT (B)(6) 2020 IN (B)(6). REVISION SURGERY IN RIGHT IN (B)(6) 2021, (B)(6)."

  Patient problems: Joint Laxity

  MAUDE report 16564106 ↗
• InjuryFeb 23, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT THE SURGERY WITH THE INSERT IN QUESTION. AFTER THE SURGERY, THE PATIENT VISITED THE HOSPITAL WITH KNEE PAIN ON (B)(6) 2022. THE SURGEON WAS GOING TO CONSULT WITH THE SALES REP ABOUT REPLACEMENT OF THE INSERT ON (B)(6) 2022. THE DETAILS ARE UNKNOWN BUT THERE IS A SUSPICION OF DAMAGE TO THE INSERT. REVISION SURGERY WAS (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2017, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Fall; Pain

  MAUDE report 13583798 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. TIBIAL REVISION WAS PERFORMED. INFORMATION ON RETAINED COMPONENTS WAS NOT AVAILABLE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10726495 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL RED SWOLLEN KNEE. IRRIGATION & DEBRIDEMENT AND POLY EXCHANGE WITH CULTURES TAKEN TO SEE IF IT WAS INFECTED. DO NOT HAVE ACCESS TO THOSE RESULTS. THE PRESENCE OF INFECTION IS UNKNOWN. DOI: (B)(6) 2019; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10010391 ↗