ATTUNE 1516-50-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295052746), received between Aug 28, 2018 and Mar 30, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN AND SWELLING. CLEANED OUT AND POLY WAS EXCHANGED. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24713230 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23467924 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS APPROXIMATELY 10 MONTHS POST-OP AND HAS TESTED POSITIVE FOR STAPH EPI. SURGEON NEEDS TO PERFORM I&D WITH POLY EXCHANGE. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22825662 ↗
• InjuryApr 4, 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 GLOBAL INSTABILITY. THE LIGAMENTS ARE CHRONICALLY LOOSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21774408 ↗
• InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE IS CURRENTLY NO REPORTED KNEE RP TIBIAL TRAY COMPONENT. THE INSERT COMPONENT PRODUCT NUMBER: 151650710 ATTUNE PS RP INSRT SZ 7 10MM LOT CODE: 9800690 REQUIRES A KNEE TIBIAL TRAY COMPONENT TO ARTICULATE WITH AT THE RP POST LEVEL. THERE AS NO TIBIA TRAY IN THE PATIENT. THIS PATIENT HAD A SPACER IN AND IT WAS FULLY REMOVED AND THEY DID NOT PUT ANYTHING BACK INTO THE PATIENT.

  Patient problems: Joint Dislocation

  MAUDE report 21584536 ↗
• InjuryFeb 19, 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 KNEE INFECTION . COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21410126 ↗
• InjuryFeb 11, 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 AND NO PATIENT CONSEQUENCE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21358119 ↗
• InjuryJan 9, 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 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: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21110718 ↗
• InjuryJan 6, 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 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 TRAILED A THICKER TIBIAL INSERT TO ADDRESS INSTABILITY AND ULTIMATELY IMPLANTED A 14 MM SIZE 7 INSERT. THE SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21086292 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHRONIC DRAINAGE FROM KNEE AND SCHEDULED FOR IRRIGATION AND DEBRIDEMENT (I&D) WITH HARDWARE REMOVAL ON (B)(6) 2024. DOI: (B)(6) 2024. DOE: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 19991987 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RECENT ATTUNE TOTAL. UNFORTUNATELY, SHE IS CONFIRMED FOR INFECTION. A POLY EXCHANGE WAS PERFORMED. A DEBRIDEMENT OF THE KNEE WAS PERFORMED AND THE POLY WAS REPLACED. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19574188 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION INVOLVING A BILATERAL POLY SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19088171 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CEMENTLESS IMPLANTS WERE REMOVED DUE TO INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18769377 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY IS DELAYED PENDING BONE SCAN RESULTS , HAS NOT BEEN RESCHEDULED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18766570 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFLAMMATION AND KNOWN INFECTION. TEMPORARY SPACER WAS PUT IN FOR STAGE ONE INFECTION. NO LOOSENING AND NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 17850417 ↗
• InjuryJul 11, 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 FLEXION/EXTENSION MISMATCH. FEMUR WAS DOWNSIZED FROM A 7 TO A 6. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17298799 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OLD POLY WAS SWAPPED OUT WITH A THICKER POLY AND FOUND THAT THE PATELLA WAS FRACTURED SO DOCTOR PUT IN NEW PATELLA. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16416317 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A TEMPORARY SURESPACE SPACER DUE TO INFECTION . DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15501942 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND ANTERIOR KNEE PAIN. THE POLY WAS UPSIZED FROM A 10 TO 14 AND THE PATELLA WAS RESURFACED IN THE REVISION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) , 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14141579 ↗
• MalfunctionOct 13, 2021Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping; Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED. A. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO, THE INCIDENT OCCURRED WHEN THE DISTRIBUTOR RECEIVED OUR IMPLANTS IN HIS WAREHOUSE, AT THAT TIME THE DISTRIBUTOR SEPARATED THE IMPLANT SO AS NOT TO PUT IT IN FOR SURGERY. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO, THE IMPLANT DID NOT LEAVE THE DISTRIBUTOR'S OFFICE AND WAS NOT USED IN ANY SURGERY. C. AFFECTED SIDE: THE IMPLANT CAME WITHOUT THE OUTER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623974 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC REPORTS THE INFECTION THAT OCCURRED AFTER THE SURGERY AND THE 1ST REVISION SURGERY DUE TO INFECTION. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE SURGERY FOR KNEE. AFTER THE SURGERY, INFECTION OCCURRED. AFTER THE INFECTION HAD SUBSIDED, ON (B)(6) 2021, THE 1ST REVISION SURGERY (TKA) WAS PERFORMED, AND THE ATTUNE CRS INSERT WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 12547913 ↗
• MalfunctionAug 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FOREIGN MATERIAL(HAIR) WAS FOUND INSIDE OF THE PACKAGE BEFORE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280179 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE SURGEON OPENED THE KNEE UP, DID AN IRRIGATION & DEBRIDEMENT, AND REPLACED THE TIBIAL INSERT GOING UP TO 2 SIZES. ALL PARTS WERE WELL-FIXED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11848325 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY SWAP WAS DONE DUE TO EQUALLY LOOSE FLEXION AND EXTENSION GAPS. DOI: (B)(6) 2019; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11552327 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11113086 ↗