ATTUNE 1517-10-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295055938), received between May 18, 2020 and Sep 4, 2025 — classified as 20 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968131 ↗
• InjuryAug 18, 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 A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828042 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS DRAINING SURGICAL WOUND FROM KNEE. KNEE WAS OPENED AND IRRIGATED POLY WAS EXCHANGED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22543131 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DEHISCENCE FOLLOWING REVISION KNEE SURGERY. PATIENT WAS BROUGHT BACK FOR A WASH OUT AND POLY SWAP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 21873285 ↗
• InjuryJan 22, 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 PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21209470 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSTOPERATIVE HEMATOMA AND SURGEON CHOSE TO PERFORM AN I&D WITH POLY EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM. THERE WAS NO ALLEGATION AGAINST ANY PRODUCT AS ALL WERE WELL FUNCTIONING, HOWEVER THE INSERT WAS EXCHANGED SO A DER IS BEING FILED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 20078538 ↗
• InjuryMar 20, 2024Adverse 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 POLY INSERT AND REPLACED WITH THINNER ONE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 18940007 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY COMPETITOR'S CONSTRUCT. THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES. THIS PC IS LINKED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18721696 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. A POLY WASHOUT WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17631029 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT (I&D) OF KNEE WAS PERFORMED. THE SURGEON SWAPPED CRS INSERT WHILE IN CAPSULE. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17508763 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT AND A LINER EXCHANGE OF AN INFECTED ATTUNE REVISION DONE ABOUT 1 YEAR AGO WOULD BE PERFORMED. THEY REMOVED A SZ 5/12MM CRS INSERT AND IMPLANTED A NEW ONE. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16485808 ↗
• InjuryMay 7, 2022Adverse 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 PAIN .THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14315614 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY SECONDARY TO ASEPTIC LOOSING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12275608 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT RECEIVED: IT WAS REPORTED THAT PATIENT HAD AN ATTUNE KNEE REPLACEMENT AND CAN¿T GET KNEE TO HEAL AND SURGERY STILL NOT HEAL. FOLLOW UP CONDUCTED WITH FURTHER INFORMATION PROVIDED: FURTHER INFORMATION ON 5-APR-2021. PATIENT STATES SHE ORIGINALLY HAD BOTH KNEES REPLACED 20 YEARS AGO WITH PARTS OF AN UNKNOWN MANUFACTURER. SHE WAS REVISED TO DEPUY COMPONENTS DUE TO LOOSENING OF THE UNKNOWN MANUFACTURER'S PARTS. SHE HAD HER LEFT KNEE REVISED TO DEPUY COMPONENTS ON (B)(6) 2019 AND THE RIGHT REVISED TO DEPUY COMPONENTS ON (B)(6) 2019. BOTH KNEES HAVE HAD SIGNIFICANT PAIN AND FEELS UNSTABLE. THE LEFT HAD AN ARTHROSCOPY DONE ON (B)(6) 2020 WITH NO IMPROVEMENT. SHE HAS HAD INJECTIONS IN BOTH KNEES WITHOUT IMPROVEMENT IN PAIN. HER XRAYS ARE "CLEAR." SHE IS PLANNING TO VISIT HER SURGEON THIS WEEK TO DISCUSS ANOTHER REVISION DUE TO THE PAIN.

  Patient problems: Impaired Healing; Joint Laxity; Pain

  MAUDE report 11664230 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN ON (B)(6) 2021 FOR POLY SWAP AND DEBRIDEMENT DUE TO FALLING AND OPENING INCISION. ON (B)(6) 2021 SHE PRESENTED WITH MRSA SO SURGEON OPTED TO PERFORM A SECOND POLY SWAP AND DEBRIDEMENT OF THE KNEE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE

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

  MAUDE report 11634007 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL WHILE CHASING DOG AND INCISION SITE WAS SPLIT OPEN. OPTED TO SWAP OUT POLY AND WASHOUT. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 11595175 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO POST OPERATIVE DRESSING. SKIN CONTINUED TO DECLINE SO SURGEON CHOSE TO INTERVENE. A THOROUGH I&D WITH POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS WERE PERFORMED. NO LOOSENING REPORTED AND NO DELAY TO SURGERY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11405904 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. LEFT SIDE IS THE AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10200263 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON REMOVED ALL PARTS AND IMPLANTED TEMPORARY COMPONENTS. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10198234 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT PRIMARY COMPETITOR KNEE TO TREAT PAIN AND EFFUSION SECONDARY TO ADVANCED DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018: PATIENT RECEIVED A RIGHT REVISION ATTUNE TKA TO TREAT PAIN AND SELLING SECONDARY TO LOOSENING OF A COMPETITOR KNEE SYSTEM. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EVACUATED A SYNOVIAL CYST AND SCAR TISSUE. THE COMPETITOR FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE COMPETITOR TIBIAL TRAY WAS LOOSENED AT THE CEMENT TO IMPLANT AND CEMENT TO BONE INTERFACE, THE CEMENT MANTLE ALONG THE TIBIAL BONE HAD A TRAMPOLINE EFFECT AND THERE WAS A CYST IN THE ANTERIOR TIBIA. THE COMPETITOR PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED COMPETITOR TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2020: PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN SECONDARY TO TIBIAL COMPONENT LOOSENING AND COLLAPSE. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND REMOVED MARKED EFFUSION AND PERIARTICULAR SCAR TISSUE. THE FEMORAL COMPONENT

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Edema; Inflammation; No Code Available; Osteolysis; Pain

  MAUDE report 10065849 ↗