ATTUNE 1516-50-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295052883), received between Dec 13, 2017 and Jun 5, 2026 — classified as 31 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25411593 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN . DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24178194 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR AN IRRIGATION AND DEBRIDEMENT OF A RTK. THE SURGEON DECIDED IT BEST TO REMOVE THE POLY AND REPLACE IT AFTER THOROUGHLY WASHING OUT THE KNEE. THERE WAS NO MORE PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22700605 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A POST OP HEMATOMA AND WAS BROUGHT TO OR FOR I&D WITH INSERT EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO PATIENT HARM OR DELAY NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hematoma

  MAUDE report 22107572 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR THOUGHT THE PATIENT KNEE WAS A LITTLE TIGHT AND DECIDED TO BRING THE PATIENT TO SURGERY AND DOWNSIZE THE POLY. NOTHING WAS MENTIONED ABOUT A PROBLEM WITH THE IMPLANTS AND TIME WAS NOT EXTENDED. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED AREA: UNK KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22069570 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REMOVAL PROCEDURE DUE TO KNEE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22005729 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTION AND DR. DECIDED TO REMOVE ALL EXISTING IMPLANTS AND PUT IN A TEMPORARY SPACER UNTIL INFECTION HAS CLEARED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20941532 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT COMES BACK IN WITH A FAILED RTK. DR FINDS, IT NECESSARY TO REMOVE ALL IMPLANTS. AND PERFORM A FULL REVISION WITH ATTUNE RP CRS, CONES AND PRESSFIT STEMS TO ALLEVIATE THE USE OF CEMENT. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20867646 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTED RIGHT KNEE. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20855783 ↗
• InjuryNov 13, 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 INFECTION OF KNEE. SURGEON SWAPPED OUT THE POLY ATTUNE 8/10MM. DOI: (B)(6) 2024 , DOR: (B)(6) 2024 , AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20678735 ↗
• InjurySep 27, 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 THROUGH THE INCISION SITE. POLY WAS TAKEN OUT AND NEW POLY WAS PUT IN. NO HARM TO PATIENT, NO DELAYS, NO BROKEN INSTRUMENTS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 20321214 ↗
• InjuryJul 16, 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: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19752642 ↗
• MalfunctionJul 8, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED STATED: WHEN WE RECEIVED THE ITEM THE PLASTIC COVER ON THE OUTSIDE OF THE BOX WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690244 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH INFECTION. WASH AND SWAP WAS NECESSARY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16380107 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANT WAS REPORTED FOR UNKNOWN REASON. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16225974 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY IMPLANT WAS REMOVED AND REPLACED DUE TO POSSIBLE RISK OF INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16003509 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WAS NOT AWARE OF EVENT UNTIL (B)(6) 2022. HENCE REPORTING DELAY. DAIR PROCEDURE FOR INFECTION. WASHOUT OF INFECTED LEFT TOTAL KNEE REPLACEMENT. COMPLEX PRIMARY KNEE IMPLANTED BY DR, PRIMARY SURGERY (B)(6) 2022. LEFT LEG HAD METAL PLATES AND SCREWS INSITU FROM PREVIOUS TRAUMA. DOI: (B)(6) 2022, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15714072 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY SWAP AND WASHOUT COMPLETED. PATIENT WENT TO THE ER WITH COMPLAINTS OF PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 14956138 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2022, EFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14654818 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR (ZIMMER BIOMET) WHICH FAILED. PATIENT UNDERWENT 1ST REVISION WHERE A ZIMMER BIOMET REVISION KNEE SYSTEM WAS UTILISED - THIS FAILED. PATIENT UNDERWENT REVISION TKR WHERE AND ATTUNE REVISION SYSTEM WAS UTILISED - THIS HAS FAILED 5 (DR (B)(6), (B)(6) HOSPITAL (B)(6) 2019) . THE ATTUNE REVISION WAS REMOVED AND REPLACED WITH A TEMPORARY SPACER ON (B)(6) 2021 ( SEE (B)(4)). PATIENT HAS NOW HAD THIS TEMPORARY SPACER REMOVED (DR (B)(6), (B)(6) HOSPITAL (B)(6) 2022) AND A COMPETITOR SILVER COATED REVISION SYSTEM UTILISED. IT IS THOUGHT THAT THIS MAY BE A LOW GRADE INFECTION WHICH IS NOT SHOWING ANY POSITIVE BACTERIAL SWAPS. DOI: (B)(6) 2021; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 13366399 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT TOTAL KNEE. THE SURGEON DID A WASHOUT WITH POLY EXCHANGE. DOI: (B)(6) 2020 ; DOR: (B)(6) 2021 ; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13167799 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THRU EMAIL BY THE PATIENT AS "TO WHOM IT MAY CONCERN. CAN YOU PLEASE TELL ME IF THERE IS ANY COMPENSATION FOR VICTIMS OF FAILED KNEE REPLACEMENTS OUTSIDE OF TAKING LEGAL ACTION? I AM LOOKING FOR HELP COVERING MY EXPENSES FOR A REVISION SURGERY I HAD TO HAVE. THANK YOU." ON (B)(6) 2014, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS END-STAGE VALGUS ARTHRITIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A TIBIAL REVISION, LEFT TOTAL KNEE TO ADDRESS ASEPTIC LOOSENING. THE TIBIAL TRAY WAS NOTED TO HAVE DEBONDED FROM THE CEMENT AND WAS IN VARUS COLLAPSE. DURING THE PROCEDURE THE SURGEON REPORTED REMOVAL OF FIBROTIC AND OSTEOLYTIC MEMBRANE FROM THE BONE. THE INSERT WAS REVISED, WHILE THE FEMORAL COMPONENT AND PATELLA REMAINED IN-SITU. DOI: (B)(6) 2014, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Adhesion(s); Osteolysis

  MAUDE report 12369927 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN EVENT IS SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018 DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744553 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I AND D WITH POLY EXCHANGE FOR UNKNOWN REASON. NO LOOSE COMPONENTS AND NO DELAY TO SURGERY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11350912 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOSS OF RANGE OF MOTION DUE TO SCAR TISSUE FORMATION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10540767 ↗