ATTUNE 1516-50-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295052609), received between Jul 26, 2017 and Sep 22, 2026 — classified as 61 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 61 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a Revision of an Attune PSRP construct was done due to patella and femoral component loosening. Tibia was well fixed, but was explanted. No allegation made against the poly. Bone scans showed a ¿hot¿ patella and femoral component indicating loosening. The patient had struggled with the knee from the beginning, and then started regressing. Their leg was very stiff and had poor ROM. All components were removed and Attune Revision was implanted. Surgeon uses CMW2 cement. Suspected cement-bone interface as components came out with cement on them. Side Affected: Left Side.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 50858150 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that doctor did washout and poly swap.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Insufficient Information

  MAUDE report 50209073 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS UNSTABLE IN BOTH FLEXION AND EXTENSION. SURGEON REMOVED THE POLY, TRIALED THICKER POLY TILL IMPLANTING AN ATTUNE SIZE 6, 16MM RP PS POLY. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24536877 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LEFT IS THE AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24244990 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23959579 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23547285 ↗
• InjuryAug 21, 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 A PAINFUL RIGHT KNEE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22859812 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO PUT IN A THICKER POLY AFTER PATELLA TENDON RUPTURED. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22359252 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POLY SWAP DUE TO HER TOTAL KNEE BEING UNSTABLE. SURGEON REMOVED THE 6X10 POLY AND WENT UP TO A 6X14. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22140237 ↗
• InjuryApr 29, 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 STIFF OF LEFT TOTAL ATTUNE KNEE WITH LIMITED MOTION. IT IS UNKNOWN WHEN THE KNEE WAS DONE. THE SURGEON DID A DEBRIDEMENT AND A TIBIAL INSERT EXCHANGE. ALL OTHER COMPONENTS ARE WELL FIXED AND RETAINED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21925243 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS SWAPPED WITH I&D FOR INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21503936 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: (B)(6) 2018: 60-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2022: 65-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED DUE TO FEMORAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND PATELLA. THE PATIENT RECEIVED AND UNKNOWN REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20621770 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNOWN INFECTION. I&D W LINER EXCHANGE PERFORMED. NO BROKEN INSTRUMENTS OR PARTS, NO HARM OR CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20321207 ↗
• InjurySep 12, 2024Adverse 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 INSTABILITY. DOI: UNKNOWN . DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20200162 ↗
• InjurySep 6, 2024Adverse 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 PAINFUL TOTAL KNEE. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain

  MAUDE report 20157121 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE HAS BEEN IN SINCE (B)(6) 2023. DEVELOPED INFECTION AND THE POLY WAS SWAPPED. DOI: UNKNOWN. DOR: MAY 10, 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19382872 ↗
• InjuryMay 20, 2024Adverse 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 PAINFUL KNEE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19351252 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE REPLACEMENT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18269525 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POOR RANGE OF MOTION. SURGEON REMOVED 10MM INSERT AND REPLACED WITH 8MM INSERT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 18236604 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH AN INFECTION. THERE WAS A WASH OUT POLY SWAP. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18170669 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS MADE AWARE THAT THE PATIENT'S KNEE MAY BE INFECTED. SURGEON SET A PLAN IN MOTION TO TAKE THE PATIENT BACK TO SURGERY FOR A FULL WASH AND CLEAN OUT, AND A POLY EXCHANGE. THE PATIENT HAD POPPED A STITCH THAT HAD CAUSED THE WOUND TO BE EXPOSED AND BECOME INFECTED. SURGEON WASHED OUT THE SURGICAL SITE, PLACED IN SOME ANTIBIOTIC BEADS, AND REPLACED THE POLY. THEY WENT BACK IN WITH THE SAME MM THICKNESS AS THE FIRST TIME BECAUSE THE KNEE WAS COMPLETELY STABLE TO BEGIN WITH. NO CONCERN WAS EXPRESSED ABOUT THE SYSTEM. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 18085330 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6).2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17916087 ↗
• InjurySep 5, 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) 2023. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17681988 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SWAPPED POLY DUE TO INSTABILITY UNRELATED TO OTHER COMPONENTS OF THE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17584011 ↗
• InjuryJul 11, 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 ON (B)(6) 2023, DUE TO INSTABILITY AND EXTENSION ISSUES. NO SURGICAL DELAY WAS REPORTED. DATE OF ORIGINAL IMPLANT WAS (B)(6) 2023. THIS REPORT IS FOR AN ATTUNE PS RP INSRT SZ 6 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 17298330 ↗