ATTUNE 1517-10-812Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295056263), received between Nov 20, 2019 and Jun 26, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED DUE TO INFECTION ALL PIECES WERE REMOVED AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NOTHING FURTHER. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25634745 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE WAS DONE DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24291930 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY EXCHANGE FOR CONFIRMED INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071942 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PREVIOUS RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AND DEVELOPED PAIN AND SWELLING IN THE KNEE AND WAS BROUGHT IN FOR INCISION AND DRAINAGE OF THE KNEE WITH CHANGING OF THE INSERT. NO COMPLICATIONS OR DELAY IN SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE. (B)(4) FOR DEVELOPED PAIN AND SWELLING IN THE KNEE. AND (B)(4) CREATED TO CAPTURE THE PREVIOUS REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23632972 ↗
• MalfunctionNov 21, 2025Difficult to Insert; Difficult to Insert

  THE IMPLANT DID NOT FIT CORRECTLY INTO THE TIBIAL COMPONENT. A NEW IMPLANT WAS OPENED. PROCEDURE WAS COMPLETED WITH A FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619774 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. A BIGGER POLY IS NEEDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23544900 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE REIMPLANT DONE ON (B)(6) 2023. PATIENT IS SHOWING SIGNS OF INFECTION AND WAS BROUGHT IN BY SURGEON FOR I&D WITH POLY EXCHANGE. THERE WAS NO DELAYS OR ISSUES IN SURGERY. DOI: (B)(6), 2023. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23015755 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR A NON-DEPUY KNEE. IN THE REVISION KNEE ARTHROPLASTY, A TISSUE MASS WAS RESECTED. AFTER THE REVISION, THE PATIENT CONTINUES TO HAVE BLOODY DRAINAGE. A THOROUGH I&D WAS PERFORMED WITH PLACEMENT OF A NEW INSERT AND RESORBABLE ANTIBIOTIC PLACED. HEMOSTASIS WAS ATTEMPTED AND CLOTTING AGENTS WERE APPLIED TO TISSUES THAT CONTINUED TO SHOW OOZING. NO PATIENT HARM OCCURRED AND NO DELAY WAS NOTED. THERE WERE NO ALLEGATIONS AGAINST ANY COMPONENTS, THE INSERT WAS SIMPLY EXCHANGED AS A PRECAUTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Tissue Injury

  MAUDE report 22859077 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THEY USED DEPUY CEMENT BUT IT'S NOT MARKED IN THE CHART AS TO WHICH SURGERY THE CEMENT WAS FOR SO THEY HAVE NO INFORMATION REGARDING CEMENT NUMBERS. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22384735 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAPPED OUT FOR I&D. THERE WAS NO BROKEN INSTRUMENT. NO HARM TO PATIENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21964124 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND UNDERWENT I&D POLY EXCHANGE FOR INFECTION. THERE WERE NO DELAYS, NO HARM TO THE PATIENT. AND NO BROKEN INSTRUMENTS. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20713131 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S (B)(6). AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267195 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE I&D SURGEON WANTED TO EXCHANGE POLY, NO REPORTED PROBLEMS, NO DELAY IN PROCEDURE, IMPLANT UNAVAILABLE FOR RETURN. DOI- UNKNOWN, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20169145 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19067054 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT OF THE KNEE. THE POLY WAS EXCHANGED WHILE IN CAPSULE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: JAN 3, 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18476121 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT¿S KNEE WAS REVISED WITH AN I&D AND POLY EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16225354 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PAINFUL KNEE. SURGEON PERFORMED A IRRIGATION AND DEBRIEDMENT WITH A STRUT GRAPH OVER THE STEM OF THE ATTUNE REVISION FEMUR. SURGEON CHANGED THE INSERT ALSO. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15915046 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. SURGEON PERFORMED I&D AND EXCHANGED THE POLY. ALL OTHER COMPONENTS ARE WELL FIXED AND RETAINED. DOI: (B)(6) 2020. DOR: (B)(6)2022. AFFECTED SIDE: LEFT KNEE AFFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13722208 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DECIDED GO AND HAVE ACUPUNCTURE IN HIS NEED FOR PAIN ON THE OPERATED KNEE. PATIENT PRESENTED SIGNS OF INFECTION. KNEE WAS DRAINED AND INFECTION WAS PRESENT. POLY INSERT WAS REMOVED AND A THOROUGH I&D WAS PERFORMED. A NEW POLY WAS IMPLANTED AND THERE ARE NO FURTHER INFO THAT CAN BE PROVIDED AT THIS TIME. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11690061 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON WASHED OUT THE KNEE AND REPLACED THE TIBIAL INSERT POLY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11536905 ↗
• InjuryMar 11, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT ATTUNE REVISION INSERT WAS SWAPPED FOR THICKER INSERT. PATIENT HAD COMPLAINED OF KNEE INSTABILITY. THE EXPLANTED POLY WAS DAMAGED AND THROWN AWAY PER HOSPITAL PROTOCOL. NO DELAY IN SURGERY. DOI: UNK, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11463854 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION AS A CONSEQUENCE OF PERIPROSTHETIC JOINT INFECTION; SEPTIC MULTI ORGAN FAILURE DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION OF THE LEFT KNEE AND EMPYEMA OF THE RIGHT KNEE AND LEFT SHOULDER DATE OF IMPLANTATION: (B)(6) 2019; DATE OF REVISION: (B)(6) 2020; (LEFT KNEE).

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10831760 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS AND DECREASE RANGE OF MOTION. THE SURGEON REMOVED A SUBSTANTIAL AMOUNT OF SCAR TISSUE AND SWAP OUT THE POLY TO A SMALLER SIZE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10712736 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POSTOPERATIVE HEMATOMA. I&D PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9347682 ↗