ATTUNE 1506-70-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10603295492061), received between Mar 2, 2018 and Sep 24, 2026 — classified as 102 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (26 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that surgeon revised for instability. No patient complications. No further information.DOI: Unknown.DOR: (b)(6) 2026.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50878005 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. (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 due to infection and pain.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50177681 ↗
• InjuryAug 7, 2026Loss of or Failure to Bond

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to loose femoral and tibial components and pain. The non-articular surface of the cemented CC femoral component shows abundant cement remaining.The non-articular surface of the cemented tibial tray shows abundant cement remaining.

  Patient problems: Pain

  MAUDE report 50172382 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25766420 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION FOR STABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25027717 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CASE HAD BEEN REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24875197 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO SURGEON SUSPICION OF INSTABILITY. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 24815696 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SURGEON SUSPICION OF INFECTION. NO OTHER INFORMATION IS KNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24691260 ↗
• InjuryFeb 26, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO SURGERY FOR TIBIAL LOOSENING. THE TIBIA WAS REVISED TO AN ATTUNE REVISION RP. IT WAS STATED THAT TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT/IMPLANT. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24461535 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A STIFF KNEE. THE TIBIA RESECTED FOR MORE TIBIAL BONE. DOI: (B)(6) 2025 , DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 23795278 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23770980 ↗
• InjuryDec 3, 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. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23706912 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE ARTHROPLASTY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23526590 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WAS REVISED DUE TO LACK OF RANGE OF MOTION (ROM). REVISED THEY FIXED TIBIA AND REMOVED MORE TIBIA BONE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23468056 ↗
• InjurySep 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POOR MOTION. THERE WAS LOOSENING OF THE TIBIA. THE LOOSENING OF THE INTERFACE WAS CEMENTED TO THE IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22970015 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 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: THE ATTUNE FEMORAL COMPONENT, TIBIAL INSERT, AND TIBIAL TRAY WERE REVISED FOR ARTHROFIBROSIS, INSTABILITY, AND PAIN.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 22671533 ↗
• InjuryJul 1, 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. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22375953 ↗
• InjuryMay 21, 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 LOOSE COMPONENTS FROM CHRONIC INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22063354 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR INSTABILITY. IMPLANTS WERE REMOVED AND AN ATTUNE REVISION WAS PLACED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22010463 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE REMOVED DUE TO PERCEIVED INFECTION. ONE STAGE REVISION WAS PERFORMED. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21985736 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY AND THE TIBIAL TRAY WAS LOOSE. CEMENT WAS STILL ON THE BOTTOM OF THE TRAY, SO IT LOOKED TO BE FROM THE CEMENT BONE INTERFACE. REVISION WAS PERFORMED. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21874653 ↗
• InjuryMar 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORD AD (B)(6) 2025 ON (B)(6) 2022, THE PATIENT C/O PINS AND NEEDLES SENSATION, ACHING, AND NUMBNESS TO HER LEFT KNEE AND LEFT FOOT. SHE IS UNDERGOING AN MRI TO EVALUATE FOR PLACEMENT OF A SPINAL CORD STIMULATOR TRIAL.

  Patient problems: Numbness; Pain

  MAUDE report 21585430 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED PATELLA, SEVERE FLEXION CONTRACTURE, AND FLEXION/EXTENSION MISMATCH. JOINT WAS EXPLANTED. TEMPORARY SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture; Joint Laxity

  MAUDE report 21571408 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD AD 28 FEB 2025: ON (B)(6) 2022, THE PATIENT C/O PINS AND NEEDLES SENSATION, ACHING, AND NUMBNESS TO HER LEFT KNEE AND LEFT FOOT. SHE IS UNDERGOING AN MRI TO EVALUATE FOR PLACEMENT OF A SPINAL CORD STIMULATOR TRIAL.

  Patient problems: Muscular Rigidity

  MAUDE report 21535529 ↗
• InjuryJan 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A 55-YEAR-OLD FEMALE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO TREAT PERSISTENT GLOBAL INSTABILITY. THE PATIENT HAD A PREVIOUS REVISION OF THE TIBIAL INSERT TO TREAT INSTABILITY AND POLY-WEAR ON (B)(6) 2018 ((B)(4)) UPON ENTERING THE JOINT, THE SURGEON NOTED THE TIBIAL TRAY WAS STABLE BUT MILDLY LOOSENED AT THE SMART-SET CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS STABLE BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED UNKNOWN TIBIAL INSERT. THE PATELLA WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE STEMMED REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2018. DOR: (B)(6) 2018 (PRIMARY TIBIAL INSERT CAPTURED ON (B)(4)). DOR: (B)(6) 2023 (UNK INSERT, FEMORAL, TRAY, CEMENT). LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21200980 ↗