ATTUNE 1506-70-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10603295492085), received between May 15, 2018 and Sep 18, 2026 — classified as 66 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 22, 2021Terminated

   Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

   Z-1314-2021 · Root cause: Packaging change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50822910 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL INFECTION. ATTUNE 6 MONTHS.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24549761 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AND A STAGE 1 KNEE REVISION. THEY PUT IN A TEMPORARY ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24078317 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIOR LEFT TOTAL KNEE ARTHROPLASTY IMPLANTS WHICH WERE REMOVED BECAUSE OF SUSPECTED INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23817040 ↗
• InjuryDec 5, 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 PERSISTENT PAIN LEFT KNEE. PATIENT HAD RETAINED HARDWARE FROM PRIOR ACL SURGERY. BONE SCAN SHOWED SOME UPTAKE ON BOTH FEMUR AND TIBIA COMPONENTS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23729262 ↗
• InjuryNov 24, 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 INSTABILITY AND CHOSE NOT TO TRIAL A DIFFERENT SIZE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23631575 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AND SPACER WAS PLACED FOR INFECTION. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23583032 ↗
• MalfunctionAug 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  INTRAOPERATIVELY WHEN OUTER STERILE PACKAGE WAS REMOVED, A HAIR WAS ON THE COVER OF THE INNER STERILE PACKAGE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT CONSEQUENCES. ANOTHER PRODUCT WAS AVAILABLE AND USED WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842297 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT, THERE WAS SEPTIC MOBILIZATION OF RIGHT KNEE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 22205511 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REVISED DUE TO RECURRENT INFECTION. IMPLANT FAILURE WAS NOT IN QUESTION.

  Patient problems: Unspecified Infection

  MAUDE report 22170616 ↗
• InjuryJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT COMPLAINED ABOUT RIGHT KNEE PAIN SINCE THE ORIGINAL SURGERY ON (B)(6) 2024 BY DOCTOR AT A HOSPITAL. PATIENT RETURNED TO THE SURGEON, AND NOTHING SEEMED TO BE AN ISSUE BASED ON X-RAYS. DOCTOR SENT THE PATIENT TO SEE ANOTHER DOCTOR. THIS DOCTOR DETERMINED THE POLY HAD BECOME DISENGAGED FROM THE TIBIAL BASEPLATE. THIS DOCTOR DID A REVISION SURGERY 2 WEEKS LATER ON (B)(6) 2025 AT A HOSPITAL. BY THIS POINT THE POLY WAS COMPLETELY DISENGAGED AND FLIPPED. UPON OPENING THE CAPSULE, THE POLY HAD TURNED WITH THE POSTERIOR SIDE FACING OUTWARD. THE FEMUR AND TIBIA TRAY WERE INSPECTED, AND NO DAMAGE WAS SEEN. THE POLY HAD WEAR POSTERIORLY AND ANTERIORLY. A NEW POLY WAS INSERTED. THIS IS ALL THE INFORMATION CUSTOMER HAD ON THIS CASE. CUSTOMER HAD ATTACHED A COPY OF THE ORIGINAL IMPLANT LOG. THE REMOVED POLY IS NOTED ON THIS ATTACHMENT AS WELL. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22158053 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN / INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22034914 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21298493 ↗
• InjuryJan 8, 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 PAIN. THE SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21102561 ↗
• InjuryNov 7, 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 KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20632098 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6)2024 MEDICAL RECORDS NOTE THE PATIENT IS ONE YEAR POST REVISION RIGHT KNEE. A FEW WEEKS AFTER THAT SURGERY THE PATIENT FELL AND DEHISCED HER WOUND. AN EMERGENCY I&D WAS PERFORMED. RECENTLY THE PATIENT HAD NOTICED SOME INCREASED SWELLING. PHYSICAL EXAMINATION NOTES MODERATE EFFUSION WITH A AN AREA OF REDNESS ALONG THE MEDIAL PROXIMAL TIBIA. CHRONIC INFECTION NOTED, AS AN ASPIRATION WAS PERFORMED. ON (B)(6)2024 ASPIRATION RESULTS FROM KNEE SHOW A GRAM-POSITIVE COCCI INFECTION. THE PATIENT IS ON ORAL ANTIBIOTICS.

  Patient problems: Cyst(s); Erythema; Fall; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 19863262 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED RTK. SURGEON WENT IN AND REMOVED ALL 4 TOTAL KNEE COMPONENTS; FEMORAL, TIBIAL, INSERT AND PATELLA COMPONENTS. AFTER AN EXTENSIVE IRRIGATION AND DEBRIDENT, SURGEON CHOOSE TO PUT IN A TEMPORARY HI DOSE ANTIBIOTIC SPACER. THE SPACER COMPONENTS CONSISTED OF AN ATTUNE CR CEMENTED FEM COMPONENT RIGHT AND AN ATTUNE ALL POLY TIBIAL COMPONENT. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19219950 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REMOVAL OF TOTAL KNEE FOR SEPSIS, IMPLANT ANTIBIOTIC SPACER. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19079867 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE PAIN AND INSTABILITY IN HIS KNEE REPLACEMENT AND SURGEON CHOOSE TO DO A KNEE REVISION TO ADDRESS. INITIAL SURGERY WAS ON (B)(6) 2022. A THICKER INSERT WAS PLACED ON (B)(6) 2023 AND A DER WAS SUBMITTED. ALL COMPONENTS WERE WELL FIXED, WELL ALIGNED, APPROPRIATELY SIZED AND WERE REMOVED ON (B)(6) 2024. JOINT LINE ALSO APPEARS APPROPRIATE. NO DELAYS NOR PATIENT HARM WAS EVIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. (B)(4) WAS CREATED TO CAPTURE THE EVENT ON ON 5/18/2023.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19020768 ↗
• InjuryMar 25, 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: LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 18967963 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18967505 ↗
• InjuryFeb 28, 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 KNEE PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18803737 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED. THE REASON FOR REVISION WAS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18746762 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POOR MOTION AND COMPLAINED OF PAIN AND INSTABILITY. A REVISION TKA WAS PERFORMED UNEVENTFULLY. A SIGNIFICANT POSTERIOR RELEASE WAS PERFORMED AND ADDITIONAL DISTAL FEMORAL RESECTION WAS NECESSARY TO GAIN EXTENSION. NO PATIENT HARM OCCURRED. NO DELAY WAS ENCOUNTERED. DOI: (B)(6) 2023, DOR:(B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 18337233 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A STIFF KNEE. SURGEON REVISED AN ATTUNE MS TO A CRS. CASE WENT WELL. DOI: UNKNOWN. DOR: NOVEMBER 16, 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18220897 ↗