ATTUNE 1516-30-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295047988), received between Jan 11, 2018 and Aug 11, 2026 — classified as 48 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient was being revised due to infection.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50208986 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ASEPTIC REVISION DUE TO PAIN. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24221737 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED THE INSERT FOR INSTABILITY. WENT FROM A ATTUNE CR RP SIZE 7X5MM TO A SIZE7X10MM. VERY STABLE AND CLOSED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23993003 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR REVISED INSERT FOR INSTABILITY. RIGHT KNEE RP CR WENT FROM A 7X5 TO A 7X8. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22124973 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTED LEFT TOTAL KNEE. THE SURGEON REMOVED THE INSERT AND PERFORMED AND WASHOUT, I&D AND POLY EXCHANGE OF INSERT. THEY WENT BACK WITH THE SAME SIZE BEING ATTUNE CR RP SIZE 7 5MM INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21944362 ↗
• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT KNEE DIDN'T FEEL RIGHT. SURGEON WENT IN AND UPSIZED POLY FROM A 5MM TO 8MM AND RESURFACED THE PATELLA. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21229896 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED THE PCL. NEEDED A PS KNEE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 20462506 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION OF LEFT TOTAL KNEE. THE SURGEON EXPLANTED THE FOUR IMPLANTS AND PERFORMED WASH OUT AND I&D. THEN PERFORMED 11/2 STAGE REVISION ALONG WITH ANTIBIOTIC CEMENT AND BIOCOMPOSITES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18987893 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. PATELLA WAS RESURFACED (NOT ORIGINALLY DONE ON PRIMARY) AND INSERT WAS EXCHANGED. DOI: (B)(6), 2021; DOR: (B)(6), 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18950782 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ER WITH A SUDDEN ONSET OF PAIN AND SWELLING IN HIS RIGHT KNEE. AN EXAMINATION AND ASPIRATION OF THE RIGHT KNEE WAS MADE. IT WAS DETERMINED THAT THE PATIENT HAS AN ACUTE INFECTION OF THE RIGHT KNEE JOINT. THE PATIENT HAD A TOTAL KNEE SURGERY ON THE RIGHT KNEE IN (B)(6) 2022. THE SURGEON ADMITTED THE PATIENT AND SCHEDULED AN I&D WITH POLY EXCHANGE DURING SURGERY THE SURGEON NOTED THAT THE TISSUES AND FLUID IN THE JOINT WERE CONSISTENT WITH INFECTION. THE POLY WAS REMOVED AND A THOROUGH I&D WAS PERFORMED. THE SURGEON ALSO NOTED THAT THE TIBIAL AND FEMORAL COMPONENTS WERE WELL PLACED AND WELL FIXED. A NEW POLY WAS IMPLANTED THE SURGEON NOTED THAT THE JOINT WAS STABLE AND HAD GREAT RANGE OF MOTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18935468 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR INSTABILITY. THERE WERE NO SURGICAL DELAYS OR HARM TO PATIENT. NO BROKEN INSTRUMENTS. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18913741 ↗
• InjuryMar 13, 2024Naturally Worn; Naturally Worn

  POLY RUB OF AFTER TWO YEARS FROM IMPLANTATION. FIRST IMPLANTATION WAS ON (B)(6) 2021 IN ANOTHER HOSPITAL. AFTER OPENING THE KNEE, THE DOCTOR SAW THE POLY RUB OFF AT THE POSTERIOR SIDE OF THE POLY. NEW POLY WAS INSERTED. DOI: (B)(6) 2021. DOE: (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18893410 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE TEP SURGERY, RIGHT LEG, ON (B)(6) 2023 AT HOSPITAL. SINCE THEN RASHES AND OTHER INTOLERANCES.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Swelling/ Edema

  MAUDE report 18749573 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18670004 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PTG IMPLANTED ON (B)(6) 2022. ALWAYS PAINFUL DESPITE PHYSIOTHERAPY. TOTAL PTG REPLACEMENT DOI: (B)(6) 2022. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18596142 ↗
• InjurySep 28, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED, WHAT THE DOCTOR DESCRIBED TO BE ¿AN OXIDATIVE POLY¿. REVISION CASE WAS DONE BY ANOTHER DOCTOR. DATE OF REVISION UNKNOWN. THE EVENT DID NOT HAPPEN DURING SURGERY. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021; DOR: UNKNOWN; AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17834060 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT ATTUNE TKR IN ANOTHER FACILITY AND UNDER ANOTHER SURGEON ON [DATE]. PRESENTED TO THIS SURGEON WITH COMPLAINT OF ANTERIOR KNEE PAIN. ON CT SURGEON NOTED A HOT SPOT UNDER THE PATELLA AND ? PATELLA LOOSENING. REVISION PROCEDURE PERFORMED, SURGEON PUT KNEE THROUGH A RANGE OF MOTION AND NOTED LAXITY IN BOTH FLEXION AND EXTENSION WITH EXISTING 5MM POLY INSERT. SURGEON REMOVED THIS INSERT AND TRIALED WITH 7MM INSERT AND WAS SATISFIED WITH ROM AND STABILITY IN FLEXION AND EXTENSION. A SIZE 7/7MM DEFINITIVE POLY WAS INSERTED. ATTENTION THEN TURNED TO THE PATELLA. THE SURGEON WAS ABLE TO EASILY REMOVE THE PATELLA COMPONENT USING A BRISTOW ELEVATOR AND REMARKED THAT THERE 'WAS ONLY SMALL AMOUNT OF CEMENT ON BOTH THE BONE AND PATELLA COMPONENT' HE PROCEEDED TO REMOVE WHAT CEMENT REMAINED, PERFORMED A CLEAN UP CUT AND RESURFACED THE PATELLA TO A 41MM DOME PATELLA. IF OTHER, DESCRIBE: REVISION OF PATELLA COMPONENT AND POLY EXCHANGE RIGHT ATTUNE TKR, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. ACTION TAKEN WHEN EVENT OCCURRED? REVISION OF PATELLA COMPONENT AND CHANGE OF POLY INSERT. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WER

  Patient problems: Joint Laxity; Pain

  MAUDE report 17238695 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE INSTABILITY DUE TO LCP FRACTURE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16551599 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHESE ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 12 MONTHS. REASON FOR REVISION: INFECTION/ PAIN".

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16378800 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; TIBIAL COMPONENT REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 15965925 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY FOR OA VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD INFECTION. THEN, THE REVISION WAS DONE, AND IMPLANTS WERE REMOVED ON (B)(6) 2022. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15751293 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT TKR ON (B)(6) 2022. PATIENT HAS PRESENTED TO DR M F (JOHN FLYNN - SURGEON CONTACT NOT AVAILABLE IN CONTACTS IN PC ONLINE MODE), WITH A PAINFUL RIGHT KNEE, SPECIFICALLY ON FLEXING THE KNEE - A VERY SEVERE SHARP PAIN RUNNING DOWN THE LATERAL SIDE OF THE KNEE. ALTHOUGH THE KNEE HAS A GOOD RANGE OF MOTION 0 DEGREES TO 120/130, THE PATIENT IS VERY UNHAPPY WITH HIS KNEE DUE TO THE PAIN ON FLEXION. A DECISION WAS MADE TO OPEN THE KNEE AND EXPLORE FOR ANY SOFT TISSUE ENTRAPMENT OR INSTABILITY. ALTHOUGH THE KNEE WAS UNIVERSALLY ON THE LOOSE SIDE, THE LATERAL OPENING ON FLEXION WAS APPROXIMATELY 3MM MORE THAN THE MEDIAL SIDE. EXCESS SOFT TISSUE WAS FOUND TO BE IMPINGING AROUND THE POSTERIOR LATERAL PART OF THE BEARING. THE 5MM POLY BEARING WAS REMOVED AND THIS SOFT TISSUE WAS REMOVED AND A 2MM THICKER BEARING IMPLANTED (7MM). THE KNEE APPEARED TO BE MORE STABLE AND THE ROM WAS MAINTAINED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15625931 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASH OUT FOR INFECTION. THE LOT#S WERE NOT PROVIDED. LEFT KNEE WASHOUT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) MEDICAL CENTER. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: SEPTIC KNEE. DID PATIENT REQUIRE REVISION SURGERY? FALSE. PATIENT STATUS/ OUTCOME / CONSEQUENCES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: REMOVAL OF HARDWARE. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. ACTIVITY LEVEL: HIGH. (B)(4). DEVICE PROPERTY OF HOSPITAL. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: HOSPITAL. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: HOSPITAL. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: HOSPITAL. DEVICE IN

  Patient problems: Unspecified Infection

  MAUDE report 15115612 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRODUCT DETAILS CLEARLY STATED POLYETHYLENE BEARING DISCARDED''. PLEASE CLARIFY, WAS THE POLY BEARING (TIBIAL INSERT) WORN? NOT KNOWN. PATIENT UNDERWENT DAIR PROCEDURE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14469408 ↗
• InjuryMay 12, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SURGEON TOOK EVERYTHING OUT TO REVISE WITH COMPETITOR PRODUCT. HE NOTICED THE POLY HAD A LOT OF PITTING AND WEAR. THE ORIGINAL CASE WAS DONE JUST OVER A YEAR AGO. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14373187 ↗