ATTUNE 1506-60-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295042877), received between Mar 14, 2019 and May 15, 2026 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF HIS PROSTHESES. SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. THE DATES WERE AND THE DER NUMBERS ARE LISTED (B)(6) 2026, (B)(6) (B)(6) 2026, (B)(6) 2026 (B)(6) CEMENT THAT WAS USED WAS DEPUY 2 WITH GENT BUT IS HOSPITAL OWNED SO NO LOT INFORMATION IS AVAILABLE IN OUR RECORDS. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25193044 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327414 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051351 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "REVISION FOR INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 23934865 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASPIRATED LAST WEEK AND IS NOW GROWING YEAST. ALL COMPONENTS WERE REMOVED IN A ONE STAGE REVISION AND NEW COMPONENTS WERE PLACED AFTER A THOROUGH I&D AND PLACEMENT OF RESORBABLE BEADS CONTAINING ANTIBIOTICS AND AN ANTIFUNGAL AGENT. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED HOWEVER THE FEMORAL SLEEVE HAD FAILED TO INGROW, LIKELY DUE TO THE FUNGUS BEING PRESENT. TIBIAL COMPONENT AND CEMENTED STEM WERE PLACED ON THE ABOVE LISTED DATE. FEMORAL COMPONENTS AND INSERT HAD BEEN REVISED ON (B)(6) 2025 FOR CONTINUED INFECTION. A DER WAS FILED UNDER (B)(4) PER OPTIMIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22747941 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4). DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22329998 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO SHOW SIGNS OF INFECTION AND WAS BROUGHT TO THE OR FOR BILATERAL KNEE REVISIONS. COMPONENTS WERE REMOVED AND THOROUGH I&DS WERE PERFORMED IN CONJUNCTION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS, AND PLACEMENT OF NEW COMPONENTS. PATIENT DID HAVE BILATERAL I&DS WITH POLY EXCHANGES ON (B)(6) 2025. AS SUCH, THE INSERTS LISTED ON THIS SUBMISSION WERE FROM THAT DATE. THE RIGHT KNEE SHOWED SIGNIFICANT HETEROTOPIC OSSIFICATION AROUND THE FEMORAL SLEEVE, SUGGESTING INFECTION ON XRAY, SO SURGEON TO CHOSE TO FASHION A STATIC SPACER UTILIZING LPS COMPONENTS TO TREAT THIS SIDE. THE LEFT SIDE APPEARED TO BE DOING BETTER, BUT SINCE HOSPITAL ADMISSION EARLIER THIS WEEK ALSO BEGIN TO SWELL. WHEN CHECKING FIXATION OF THE FEMORAL COMPONENT, THE FEMORAL SLEEVE WAS ABLE TO BE REMOVED WITHOUT SIGNS OF BONY INGROWTH. LACK OF INGROWTH APPROXIMATELY SEVEN (7) WEEKS POST IMPLANTATION SUGGESTS THIS TOO WAS INFECTED. TIBIAL COMPONENT AND STEM WERE LEFT IN PLACE ON THE LEFT SIDE SINCE IT WAS WELL FIXED. NO DELAY NOR PATIENT HARM WAS NOTED. WHILE RESULTS ARE NOT YET AVAILABLE, SURGEON DOES BELIEVE INFECTION WAS STILL PRESENT AT THE TIME OF THIS PROCEDURE. THIS INFEC

  Patient problems: Extraskeletal ossification; Unspecified Infection

  MAUDE report 22159259 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUES TO REMAIN INFECTED. SURGEON ELECTED TO REMOVE SOME COMPONENTS AND FUSE THE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22027186 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21938206 ↗
• InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21548495 ↗
• InjuryJan 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THE FEMUR AND THE TIBIA COMPONENTS WERE LOOSE. LOOSENING INTERFACE WAS THE CEMENT IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21241764 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: (B)(6) 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461670 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TKA. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 19940331 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033301 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: PAIN & LOOSENING

  Patient problems: Pain

  MAUDE report 18977720 ↗
• InjuryNov 15, 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 NAUSEA AND VOMITING AND RE-ADMITTED TO HOSPITAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: MEDICAL WORKUP RESULTING IN DX OF SHOWER EMBOLI AND TREATED WITH ELIQUIS

  Patient problems: Embolism/Embolus; Nausea; Vomiting

  MAUDE report 18138742 ↗
• InjuryOct 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION OF ATTUNE REVISION TIBIAL TRAY, SLEEVE AND STEM DUE TO LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 17960104 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TIGHTNESS. TIBIA WAS REVISED AND REMOVED MORE BONE- RE IMPLANTED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17738029 ↗
• InjuryJun 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A DISTAL FEMUR REPLACEMENT (B)(6) 2022. ON (B)(6) 2022, HAD A POLY EXCHANGE. ON (B)(6) 23, SUFFERED A DISLOCATED KNEE. THE SURGEON DECIDED TO PERFORM A KNEE FUSION. DISTAL FEMUR, POLY INSERT, TIBIAL BASE, TIBIAL SLEEVE AND STEM WERE REMOVED. NEW STEM, FEMORAL STEM, FEMORAL ADAPTER AND INTERCALARY SEGMENT WERE IMPLANTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 17039696 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RIGHT KNEE WAS REVISED DUE TO INFECTION. A MOBILE SPACER WAS PLACED AND ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16761532 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN (NON-PERSISTENT). EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Pain

  MAUDE report 16062995 ↗
• InjuryDec 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIAL COMPONENTS OF PATIENT'S RIGHT REVTKR BECAME LOOSE. SURGEON PERFORMED THE FIRST REVISION ON (B)(6) 2022 BUT DIDN'T KNOW THE CAUSE OF THE LOOSENING. HE HAD TO REMOVE FEMORAL COMPONENT TO GAIN ACCESS TO THE TIBIA, AND THEN REVISED TIBIA.

  Patient problems: Insufficient Information

  MAUDE report 15960958 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACED PLACED. NO PATIENT HARM OCCURRED. A POLY EXCHANGE AND I&D WAS PERFORMED ON (B)(6) 2022. DOI (B)(6) 2022, DOR (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15902633 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON THE (B)(6) 2022 WHERE ATTUNE REVISION IMPLANTS WERE UTILISED. THE PATIENT PRESENTED FOR A REVISION PROCEDURE ON THE (B)(6) 2022 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15579744 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493936 ↗