ATTUNE 1518-20-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 10603295056683), received between Aug 8, 2017 and Sep 30, 2026 — classified as 330 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (23 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 342 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was infected, doctor removed all components. Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50947794 ↗
• InjuryJul 28, 2026Loss of or Failure to Bond

  It was reported that patient came in for a patella revision for a loose patella. X-rays show the patella appears to be loose and will be replaced with another Attune patella.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected side: Left knee.

  Patient problems: Insufficient Information

  MAUDE report 50056094 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had knee replacements surgery in 2024 on both knees. Following the knee bilateral replacement procedure, the patient experienced a series of adverse events including infection, wound dehiscence, bleeding, allergic reaction to nickel, foreign body reaction, loss of range of motion, knee swelling, night sweats, scar tissue formation, and two falls. The infection required intravenous antibiotics, and allergy testing confirmed sensitivity to nickel. The patient continues to experience significant pain and has a revision planned for the right knee, with no plans for the left knee at this time. A successful bilateral total knee arthroplasty was performed using DePuy Synthes implants and competitor cement on (b)(6) 2024. No intraoperative complications were noted.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50055547 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Unknown Knee Femoral, Unknown Knee Tibial Tray, and Unknown Knee Tibial Insert were involved in a knee replacement event. The patient experienced multiple complications following bilateral knee replacement surgery, including infection, wound dehiscence, bleeding, allergic reaction to nickel, foreign body reaction, hair loss, loss of range of motion, knee swelling, night sweats, scar tissue formation, and falls. The patient required intravenous antibiotics and underwent allergy testing, confirming nickel sensitivity. A successful bilateral total knee arthroplasty was performed using DePuy Synthes implants and competitor cement on (b)(6) 2024This report is for the left knee.

  Patient problems: Adhesion(s); Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection

  MAUDE report 50055409 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25766405 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  DUE TO PAIN AFTER TKA, SCINTIGRAPHY EXAM WAS PERFORMED. EXAM SHOWED POSSIBLE LOOSENING OF IMPLANT. DECISION HAS BEEN DONE TO EXPLANT PROSTHESIS AND IMPLANT A REVISION SYSTEM. IT WAS LATER ADDED THAT NO LOOSENING WAS OBSERVED.

  Patient problems: Pain

  MAUDE report 25354349 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED TOTAL KNEE. SURGEON TOOK OUT OLD PARTS AND PUT IN A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24114386 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DPO_10004_10008. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE CONTRACTURE S/P TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 02 JUL 2014, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, MANIPULATION UNDER ANESTHESIA. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151820035, LOT NUMBER ID: 7783853, COMPONENT: PATELLAR, DESCRIPTION: ATTUNE PATELLA MEDIALIZED DOME 35MM CEMENTED AOX.

  Patient problems: Septic loosening

  MAUDE report 24080035 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24006140 ↗
• InjuryDec 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO KNEE INSTABILITY. IT WAS DUE TO POOR SELECTION ON POLY TO SUPPORT FLEXION AND EXTENSION GAPS. THE POLYETHYLENE WAS UNDERSIZED. THE PATIENT UNDERWENT THE POLY SWAP AND PATELLA EXCHANGE. DOI: (B)(6) 2016. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23842429 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PREVIOUS LEFT TOTAL KNEE DONE BY (B)(6) WITH ATTUNE CR FB MEDIAL STABILIZED KNEE. SHE ENDED UP GETTING A PATELLA TENDON RUPTURE AND WAS BRING FOR REVISION. THE MS LEFT 6X8MM INSERT WAS REMOVED AND A NEW MS LEFT 6X6MM WAS IMPLANTED. THE 35M PATELLA COMPONENT ALONG WITH THE WHOLE PATELLA WERE EXCISED. NO COMPLICATIONS OR DELAY IN SURGERY. DOI- (B)(6) 2024. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23757830 ↗
• InjuryDec 3, 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 INFECTION. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23706749 ↗
• InjuryNov 24, 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 INSTABILITY AND CHOSE NOT TO TRIAL A DIFFERENT SIZE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23631620 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT APPEARED TO BE OCCURRING FOR A WHILE. SURGEON DECIDED TO REMOVE IMPLANTS IMPLANT AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23393543 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA ON BOTH KNEE JOINTS, AND FOR THE LEFT KNEE THE PRODUCT IN QUESTION WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. POSTOPERATIVELY, IT WAS CONFIRMED THAT THE PATIENT HAD PAIN IN THE LEFT KNEE. AS THE PAIN HAS NOT SUBSIDED, REVISION PATELLAR REPLACEMENT SURGERY WAS PERFORMED. REGARDING THE RELATIONSHIP BETWEEN THIS INCIDENT AND THE PRODUCT, THE SURGEON COMMENTED THAT THE PATELLAR OSTEOTOMY WAS INSUFFICIENT, WHICH MAY HAVE CAUSED THE PF PRESSURE TO INCREASE. ALSO, THE SURGEON COMMENTED THAT EXTERNAL ROTATION OF THE FEMUR WAS A POSSIBLE CAUSE. AN ADDITIONAL OSTEOTOMY WAS PERFORMED AND THE PATELLA WAS REPLACED IN A SLIGHTLY MEDIAL POSITION, AND THE SURGERY WAS COMPLETED.

  Patient problems: Pain

  MAUDE report 23049575 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESECTION FOR INFECTION, I&D POLY EXCHANGE PERFORMED 6-28-25. THE PATIENT CONTINUED TO HAVE WOUND PROBLEMS AND DRAINAGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22842927 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22787174 ↗
• MalfunctionAug 6, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A BOX FELL ON THE PACKAGING AND PIERCED THE OUTER LAYER. IT WAS NOT USED DUE TO CONCERNS OF THE PACKAGING INTEGRITY BEING COMPROMISED. THERE WAS NO SURGICAL DELAYS, DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728995 ↗
• InjuryJul 17, 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 INFECTION. IMPLANTS WERE REMOVED, THERE WAS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO THE IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22530879 ↗
• MalfunctionJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED: UPDATE RECEIVED FOR: CLINICAL ADVERSE EVENT: PATELLAR CREPITUS.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22480805 ↗
• InjuryJul 2, 2025Loss of or Failure to Bond; Fracture; Noise, Audible; Loss of or Failure to Bond; Fracture; Noise, Audible

  IT WAS REPORTED THAT IN 2016, PATIENT HAD A TOTAL KNEE REPLACEMENT THAT NEVER STOPPED HURTING, BUCKLING OR SWELLING. THE DOCTOR KEPT SAYING IT WOULD GET BETTER. PATIENT GOT SEVERAL SECOND OPINIONS AND THEY ALL JUST WANTED TO REPLACE RIGHT KNEE FIRST. PATIENT NEEDED THE PAIN AND SWELLING REDUCED FROM THE LEFT LEG IN ORDER TO SUPPORT THE RIGHT LEG SURGERY. ONE DOCTOR SAID THERE WAS A MECHANICAL IMPLANT FAILURE BUT ONLY OFFERED THERAPY AGAIN. PATIENT FINALLY FOUND A DOCTOR WHO WOULD GO IN. IN 2023, PATIENT HAD A REVISION. THE DOCTOR CLEANED OUT THE SCARRED TISSUE AND NOTICED THE POLYETHYLENE WAS BROKEN AND NEEDED TO BE REPLACED, SO THAT WAS DONE. THE PAIN STILL DID NOT STOP, AND KNEE STARTED TO REALLY BUCKLE ALMOST CAUSING PATIENT TO FALL TO THE GROUND. IN 2025, IN THE BATHROOM, THE PATIENT FELL AFTER GETTING UP UNSTEADILY ON THEIR FEET. THE NEXT DAY PATIENT FELT THEIR KNEECAP TURN TO THE LEFT AND IT MADE A WEIRD NOISE TO THE TOUCH. IT WAS PAINFUL TO WALK. WHEN PATIENT SAW THE DOCTOR, HE SENT THEM FOR A CT SCAN. THE SCAN SHOWED THAT THE PATELLAR COMPONENT WAS LOOSE. SO, PATIENT HAD TO HAVE ANOTHER REVISION IN 2025. THE SURGERY SHOWED THE BUTTON WAS BROKEN, THE COMPONENT WAS ROCKING AN

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 22381543 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE. COMPONENTS WERE REMOVED AND NEW IMPLANTS USED AS TEMPORARY SPACER. THERE WERE NO COMPLAINTS OR DELAYS. COMPONENTS UNAVAILABLE FOR RETURN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22338831 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE AND SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH FUNCTIONAL SPACER. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS WERE NOT BEING RETURNED. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22140773 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTS IN CLINIC WITH WHAT APPEARS TO BE A LOOSE PATELLAR COMPONENT AND IS SCHEDULED TO REVISE. XRAYS APPEAR TO SHOW SIGNIFICANT BONE LOSS OF PATELLA. OPERATIVELY, PATELLAR COMPONENT WITH CEMENT STILL ATTACHED IS LOOSE AND PATELLAR BONE HAS RESORBED. ESSENTIALLY ONLY A CORTICAL SHELL IS REMAINING. SURGEON NOTES THIS IS A THE FIRST TIME IN HIS 30 YEAR CAREER HE HAS ENCOUNTERED THIS FINDING. A COMPETITIVE IMPLANT IS SEWN INTO THE EXISTING BONE, WHICH IS MINIMAL AT BEST, ALONG WITH NATIVE SOFT TISSUE. SURGEON ROUTINELY UTILIZES DEPUY 2 CEMENT FOR HIS PRIMARY KNEE REPLACEMENTS, BUT IS HOSPITAL OWNED SO NO LOT INFORMATION IS AVAILABLE. THIS IS STORED AT THE FACILITY AND HAND MIXED IN AN OPEN BOWL. THAT IS THE ONLY INFORMATION THAT IS AVAILABLE. CEMENTED FEMORAL AND TIBIAL COMPONENTS ARE FOUND TO BE WELL FIXED, AND THE SAME BATCHES OF CEMENT WERE UTILIZED TO CEMENT ALL 3 COMPONENTS. NO PATIENT HARM NOR DELAY IS NOTED. THERE WAS A PATELLA LOOSENING AT BONE/CEMENT INTERFACE. CEMENT MANUFACTURER IS DEPUY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching

  MAUDE report 22125124 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF WHAT WILL BE A TWO STAGE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22063862 ↗