ATTUNE 1504-10-208Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10603295041795), received between Aug 10, 2017 and Apr 8, 2026 — classified as 105 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (21 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 110 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND SHOWED SIGNS OF HAVING A LOOSE IMPLANT. DOCTOR REVISED BOTH THE FEMORAL SIDE AND THE TIBIAL SIDE. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24821059 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LACKED FULL EXTENSION. ALL IMPLANTS WERE WELL FIXED. IN THIS SURGERY ADDITIONAL DISTAL FEMUR BONE WAS REMOVED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 24690820 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICES WERE EXPLANTED DUE TO REMAINING INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23922823 ↗
• InjuryOct 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT THE IMPLANT CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23380827 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BELIEVED THAT HE WAS EXPERIENCING AN ALLERGIC REACTION TO THE COCR IMPLANTS. SURGEON WAS NOT CONVINCED THAT THE PATIENT HAS AN ALLERGY TO NICKEL BUT DECIDED TO EXPLORE THE JOINT FOR LOOSENING, AND IF NO LOOSENING WAS FOUND, TO REVISE THE TKA USING OXINIUM AND TITANIUM IMPLANTS. CEMENT MANUFACTURER WAS COMPETITOR. A TWO-HOUR COMPLETE REVISION WAS PERFORMED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21934595 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DENTAL PROCEDURE RECENTLY AND THEN HE GOT AN INFECTION IN HIS KNEE. COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21546925 ↗
• InjuryJan 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION - ASEPTIC. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: RIGHT KNEE. TREATMENT / IMPACT: REVISION FOR ASEPTIC LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 21244709 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST TKA WITH POOR MOTION AND A KNEE REVISION IS SCHEDULED. AFTER ANESTHESIA IS PERFORMED, A MANIPULATION IS PERFORMED AND FLEXION IS FOUND TO BE SATISFACTORY, HOWEVER FULL EXTENSION IS NOT ABLE TO BE OBTAINED AND A FEMORAL SIDE REVISION IS PERFORMED UNEVENTFULLY WITH NO DELAY AND NO PATIENT HARM IS NOTED. FULL EXTENSION IS ACHIEVED WITH MINIMAL BONE RESECTION OF THE FEMUR AND POSTERIOR CAPSULAR RELEASE. A LATERAL RELEASE WAS ALSO PERFORMED TO ALLOW FOR BETTER PATELLAR TRACKING. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 21061253 ↗
• MalfunctionJun 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK SYNDROME. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Insufficient Information

  MAUDE report 19448126 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: UNK. DATE OF REVISION #1: (B)(6) 2023. DATE OF REVISION #2: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19229595 ↗
• InjuryApr 11, 2024Off-Label Use; Off-Label Use

  SURGEON IMPLANTED ATTUNE SZ 8 FEMUR. DISCOVERED THAT IT WAS TOO WIDE FOR PATIENT¿S ANTERIOR FEMUR AND RUBBING ON IT BAND AND TISSUE ON LATERAL ASPECT OF LEG. AFTER DISCUSSION SURGEON DECIDED TO CUT SLICER OF FEMORAL COMPONENT OFF THE LATERAL SIDE OF ANTERIOR FLANGE. HE BURRED DOWN TO SMOOTH EDGE. HE WAS INFORMED OF THE OFF LABEL USAGE OF THIS AND DECIDED TO CONTINUE. NO OTHER INFO IS TO BE OBTAINED OR GIVEN.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19089019 ↗
• InjuryMar 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  VOLUNTARY REPORT RECEIVED: THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAD RIGHT KNEE REPLACED IN 2017. THE SURGICAL PROCEDURE APPEARED TO HAVE GONE WELL FOR ABOUT THE FIRST THREE MONTHS. THEN PATIENT BEGAN OR CONTINUED TO HAVE PAIN IN HIS RIGHT KNEE. PATIENT FOLLOWED UP WITH THE SURGEON WHO DID X-RAYS AND FOUND NO ISSUES. THE PROBLEMS CONTINUED AND PATIENT AGAIN WENT IN FOR ONE-YEAR POST OP APPOINTMENT. PATIENT WAS TOLD THAT SOMETIMES KNEE JOINTS DON'T FIT AS WELL FOR SOME PATIENTS. THE PAIN CONTINUED AND BECAME SO INTENSE AT THE BEGINNING OF 2023 THAT PATIENT SOUGHT ASSISTANCE FROM A DIFFERENT SURGICAL GROUP. THE X-RAYS IMMEDIATELY SHOWED THAT THE ORTHOPEDIC JOINT WAS MOVING IN PATIENT'S LEG. PATIENT WOULD HAVE TO HAVE A REVISION SURGERY FOR CORRECTION. PATIENT HAD THIS SURGERY ON (B)(6) 2023. IT WAS TOLD BY THE SURGEON THAT THE ORIGINAL REPLACEMENT FAILED BEFORE PATIENT¿S KNEE WAS EVEN CLOSED UP AS NONE OF THE CEMENT ADHERED TO ANY PART OF THE ARTIFICIAL JOINT. THE NEW SURGEON HAD TO DO EXTENSIVE DEBRIDEMENT OF THE BONES AS THE CEMENT WAS IN THE BONES. PATIENT TOLD BOTH PARTS OF THE ORIGINAL REPLACEMENT JUST POPPED OUT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 18968458 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA AND CEMENT X 1. ON (B)(6) 2022, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO PAIN, JOINT INSTABILITY AND SUSPECTED TIBIAL TRAY LOOSENING. INTRAOPERATIVELY, SCAR TISSUE AND SYNOVITIS WAS IDENTIFIED. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THERE WAS BONE LOSS NOTED ON THE POSTERIOR ASPECT OF THE FEMORAL CONDYLES. ALL COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR CONSTRUCT WITH EXCEPTION OF THE PATELLA THAT REMAINED IN SITU. (B)(6) 2017 DOI .(B)(6) 2022 DOR (RIGHT KNEE).

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 18913220 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND TORE THE QUAD TENDON. SURGEON DECIDED TO RESURFACE THE PATELLA WHILE HE WAS THERE. DOI: (B)(6) 2023. DOR: JAN 15, 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 18562821 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: OCT 17, 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18527167 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CLOSED DISPLACED FRACTURE OF LESSER TROCHANTER OF RIGHT FEMUR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: (B)(6) 2019. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Limb Fracture

  MAUDE report 18159863 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPICIOUS PERIPROSTHETIC INFECTION. TWO FEMORAL INTERFERENCE SCREWS IMPLANTED IN PREVIOUS ACL RECONSTRUCTION SURGERY WERE ALSO REMOVED. THE REPORT CONCERNS THE ENTIRE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 16984973 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. SURESPACE ARTICULATING SPACER MOLD WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16938202 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CEMENTED TIBIA LOSENING RIGHT. FIRST IMPLANTATION 2020. DOI: 2020. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16706643 ↗
• MalfunctionMar 10, 2023Tear, 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 THE SEAL OF THE STERILE CONTAINER WAS BROKEN BEFORE GIVEN TO NURSE SO IMPLANT IS NOT ABLE TO BE USED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521950 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME STIFF IN FLEXION. THE SURGEON DOWNSIZED THE FEMUR AND DECREASED THE POLY SIZE. ALL LIGAMENTS WERE INTACT. ALL COMPONENTS WERE WELL FIXED. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2020, DOR- (B)(6) 2022, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 16094963 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16088386 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DOING WELL FOR SEVERAL MONTHS AND THEN DEVELOPED LOSS OF RANGE OF MOTION. INFECTION WORKUP WAS NEGATIVE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16004255 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15895506 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15837977 ↗