ATTUNE 1516-20-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295045793), received between Mar 8, 2018 and Jun 23, 2026 — classified as 19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION AFTER INFECTION OF KNEE. THIS REPORT IS RELATED TO COMPLAINTS (B)(4) AND (B)(4) WHICH CAPTURES PREVIOUS REVISIONS.

  Patient problems: Unspecified Infection

  MAUDE report 25595397 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF EXTREME TIBIAL PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24647647 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED; POLY SWAP DONE FOR SUSPECTED INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE/

  Patient problems: Unspecified Infection

  MAUDE report 23341233 ↗
• InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LOCKING MECHANISM FAILED TO ENGAGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22738529 ↗
• InjuryJun 23, 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. AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 22307589 ↗
• MalfunctionOct 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEFECTIVE LOCKING MECHANISM WOULD NOT ALLOW THE INSERT TO SEAT PROPERLY IN TIBIA TRAY. DOE : (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20532219 ↗
• 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 20445668 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN I&D WITH POLY EXCHANGE DUE TO INFECTION. THE FIXED BEARING 8MM CR BEARING WAS EXCHANGED FOR 10MM MS BEARING. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19215629 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND WE DID A I&D WASHOUT WITH POLY EXCHANGE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17049893 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AROUND HIS INCISION DEVELOPED. PATIENT WAS WASHED OUT AND A NEW POLY WAS INSERTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15614345 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND ARTICULATING SPACER WAS PLACED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15282202 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN. SURGEON BELIEVES THERE IS TOO MUCH LAXITY. INSERT IS REMOVED AND A THICKER INSERT WAS PLACED UNEVENTFULLY, NO PATIENT HARM REPORTED. CEMENT IS HOSPITAL OWNED SO NO INFO IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15051789 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT A PRIMARY RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED EXCISING SCAR TISSUE AND SOME TIBIAL BONE LOSS. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATION'S. DOI: (B)(6) 2015, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11625225 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO GLOBAL INSTABILITY. INSERT WAS SWAPPED FOR A LARGER ONE TO PROVIDE STABILITY. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10288987 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. TIBIAL LIGHTS UP IN BONE SCAN. UPON REMOVAL, THE TIBIA DID NOT SEEM GROSSLY LOOSE. X-RAYS DID NOT HAVE OBVIOUS SIGNS OF LOOSENING EITHER. THE SURGEON TOOK OUT THE 2 TIBIA PARTS AND LEFT THE FEMUR AND PATELLA. THE SURGEON IMPLANTED A ATTUNE REVISION SIZE 4 TRAY, 37 SLEEVE AND A 14X110 STEM. A COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10138452 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SALES REP WAS NOTIFIED THAT THE PATIENT HAD AN INFECTED LEFT KNEE. THE SURGICAL REMOVAL OF IMPLANTS WAS PLANNED FOR ON AN URGENT BASIS ON THIS DAY. SURGERY WAS PERFORMED IMPLANTS WERE REMOVED AND A PROSTALAC KNEE SPACER WAS IMPLANTED. DOI: (B)(6) 2018, (B)(6) 2019 (INSERT). DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9907898 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISED TO ADDRESS INFECTION, WITH STAGE ONE EXPLANTATION OF DEPUY PRODUCTS, AND PLACEMENT OF ANTIBIOTIC SPACER. DOI: (B)(6) 2019. DOR: (B)(6) 2019. TREATMENT: EXPLANTATION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA, PLACEMENT OF ANTIBIOTIC-LADEN SPACER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9837935 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, INSTABILITY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PRE- AND -POST-OPERATIVE DIAGNOSIS ALSO INDICATED FEMORAL COMPONENT LOOSENING, HOWEVER, THERE IS NO MENTION OF FEMORAL COMPONENT LOOSENING WITHIN THE OPERATIVE NOTE. THE FEMORAL COMPONENT WAS REMOVED USING AN OSTEOTOME AND SAW. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9278549 ↗
• MalfunctionFeb 12, 2019Use of Device Problem; Use of Device Problem

  AFTER AN ATTUNE SURGERY, IT WAS SEEN THAT AN ATTUNE PE INLAY WITH AN EXPIRY DATE NOV. 2018 WAS IMPLANTED. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332262 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY AFTER A FALL. EXCHANGED FOR ONE SIZE THICKER INSERT. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7453624 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TKR. DR (B)(6) , (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2016. REVISION (B)(6) 2018 PATIENT PRESENTED WITH SHIN PAIN A FEW MONTHS AGO. SOME MCL LAXITY FROM EARLY POST OP BUT PATIENT AS NOT BOTHERED BY THIS. FEMALE PATIENT INITIALS (B)(6). (B)(6) REP WAS NOT PRESENT FOR THIS CASE. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7324080 ↗