ATTUNE 1518-10-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10603295056621), received between Jan 11, 2018 and Sep 22, 2026 — classified as 80 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 50858166 ↗
• InjuryJun 15, 2026Use of Device Problem

  IT WAS REPORTED THAT PATIENTS' IMPLANTS LOOKED GOOD AT 6 WEEKS. THEN DESCRIBED PATELLA TRACKING ISSUES. REVISION SURGERY DONE (B)(6) 2025 LATERAL RETICULAR RELEASE. STILL SHOWED PATELLA MALALIGNMENT. REVISED ALL COMPONENTS ON (B)(6) 2026 DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25503445 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085081 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. THERE WAS TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24079850 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE, AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862909 ↗
• InjuryOct 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A LINER EXCHANGE TO RULE OUT INFECTION. DURING THE REVISION, THE IMPLANT PATELLA FELL RIGHT OFF. IT WAS LOOSE AT THE IMPLANT CEMENT INTERFACE. IT WAS NOT REPLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23437906 ↗
• InjuryMay 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AVN PATELLA, UPSIZED POLY. PATELLA WAS LOOSE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Necrosis

  MAUDE report 22107879 ↗
• InjuryMay 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 LOOSE COMPONENTS FROM CHRONIC INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22063356 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD AD 28 FEB 2025. ON (B)(6) 2022, THE PATIENT C/O PINS AND NEEDLES SENSATION, ACHING, AND NUMBNESS TO HER LEFT KNEE AND LEFT FOOT. SHE IS UNDERGOING AN MRI TO EVALUATE FOR PLACEMENT OF A SPINAL CORD STIMULATOR TRIAL.

  Patient problems: Muscular Rigidity

  MAUDE report 21535512 ↗
• InjuryFeb 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT LATERAL PEG OF THE PATELLA SNAPPED OFF UPON THE PATIENT FALLING. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall

  MAUDE report 21449188 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO AN INFECTION. ALL PARTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DATE OF THE ORIGINAL PRIMARY SURGERY WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21439231 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION FOR PAIN AND SUSPICIOUS SPECT-CT. THE PATIENT REQUIRES REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: Pain

  MAUDE report 21375077 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 21173752 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. NO HARM TO PATIENT. NO DELAYS. NO BROKEN INSTRUMENTS. DOI- (B)(6) 2019. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21113127 ↗
• InjuryJan 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO COMPLAINT OF PAIN. THE PRIMARY COMPONENTS WERE AN ATTUNE SIZE 7 PS FEMUR, ROTATING PLATFORM TIBIAL BASE PLATE, A SIZE 7 X 10 MM INSERT AND 32MM ANATOMIC PATELLA. DURING THE CASE, IT WAS DISCOVERED THAT THE PATELLA COMPONENT WAS LOOSE. THE SURGEON REMOVED THE PATELLA COMPONENT, CLEANED OFF THE BONE RE-DRILLED THE PEG HOLES AND IMPLANTED A 32 MM ANATOMIC PATELLA. HE ALSO TRIALED A THICKER TIBIAL INSERT TO ADDRESS INSTABILITY AND ULTIMATELY IMPLANTED A 14 MM SIZE 7 INSERT. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21091085 ↗
• InjuryJan 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO COMPLAINT OF PAIN. THE PRIMARY COMPONENTS WERE AN ATTUNE SIZE 7 PS FEMUR, ROTATING PLATFORM TIBIAL BASE PLATE, A SIZE 7 X 10 MM INSERT AND 32MM ANATOMIC PATELLA. DURING THE CASE, IT WAS DISCOVERED THAT THE PATELLA COMPONENT WAS LOOSE. THE SURGEON REMOVED THE PATELLA COMPONENT, CLEANED OFF THE BONE, RE-DRILLED THE PEG HOLES AND IMPLANTED A 32 MM ANATOMIC PATELLA. THE SURGEON ALSO TRIALED A THICKER TIBIAL INSERT TO ADDRESS INSTABILITY AND ULTIMATELY IMPLANTED A 14 MM SIZE 7 INSERT. THE SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21086358 ↗
• InjuryDec 9, 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: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20882599 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE HER EXTENSOR MECHANISM. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 20504032 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO B. CAN YOU CONFIRM IF DEPUY CEMENT WAS USED DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. THE SURGEON USES DEPUY CMWLL WITH GENTAMICIN.

  Patient problems: Unspecified Infection

  MAUDE report 20500435 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A THICKER POLY AND PATELLA WAS SWAPPED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20461040 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR DEEP VEIN THROMBOSIS OF LEFT LOWER EXTREMITY. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 31 JAN 2019. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20444230 ↗
• InjuryOct 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATELLA WAS POTENTIALLY LOOSE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20342950 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE INFECTION, SURGEON EXPLANTED COMPONENTS AND REVISING WITH TEMPORARY SPACER. THERE WAS NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19312690 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM SALES REP STATING THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18476289 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18184487 ↗