ATTUNE 1516-30-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295047896), received between Jul 17, 2017 and Mar 4, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 24506426 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TIGHT IN FLEXION AND LIMITED ROM. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21336806 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED AND IMPLANTS WERE EXPLANTED. ARTICULATING SPACER WAS PUT IN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18020403 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS SWAPPED FOR INSTABILITY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17745889 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WAS PERFORMED WITH POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14773076 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION, ATTUNE KNEE WAS EXPLANTED AND CEMENT SPACER USED. THERE ARE NO IMPLANTS AVAILABLE FOR RETURN, NO DEFICIENCY WITH THE PRODUCT, AND NO ADDITIONAL INFORMATION TO PROVIDE. LOT NUMBER FOR FEMUR UNKNOWN, NUMBERS/SIZE OF PATELLA ALSO UNKNOWN. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14381805 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13215408 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RANGE OF MOTION 0/0/60°. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2014. (LEFT KNEE). TREATMENT: NONE. PATELLA WAS NOT RESURFACED AT PRIMARY.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10563818 ↗
• InjuryAug 26, 2020Unintended Movement; Unintended Movement

  IN THE EVENT DESCRIPTION OF (B)(4), IT WAS STATED THAT "INLAY SPIN OUT; (B)(6) 2014 - AFTER AN UNHAPPY MOTION, 14 DAYS AFTER ATTUNE TKA AN INLAY SPIN OUT HAPPENED. SHE CAME IN 60 DEGREE FLEXION. THE WOUND, SENSIBILITY AND VASCULARISATION WERE WITHOUT PATHOLOGICAL FINDINGS. (B)(6) 2014 UNDER ANESTHESIA UNBLOODY REPOSITION COULD BE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10456637 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A REVISION OF THE LEFT KNEE SECONDARY TO PAIN, DECREASED RANGE OF MOTION AND SUSPECTED TIBIAL LOOSENING. INTRAOPERATIVELY, THE SURGEON DISCOVERED TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE AND MEDIAL TIBIAL OSTEOLYSIS. THE FEMORAL AND PATELLAR COMPONENTS WERE WELL-FIXED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2016. DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

  MAUDE report 9548146 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. THE INSERT WAS EXCHANGED DURING I AND D. DOI: (B)(6) 2018 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7889388 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. WASH OUT AND POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7845657 ↗
• InjuryJul 17, 2017Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  CLINICAL DER STATES AE RECEIVED FOR DEEP VENOUS THROMBOSIS.

  Patient problems: No Information; Thromboembolism

  MAUDE report 6716884 ↗