ATTUNE 1506-60-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295042907), received between Oct 5, 2018 and Sep 24, 2026 — classified as 62 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 65 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Pain

  MAUDE report 50891206 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED; SPACER PLACED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25448511 ↗
• InjuryFeb 24, 2026Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 26 JAN 2026. DATE OF IMPLANT: (B)(6) 2008. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: KNEE REPLACEMENT; WERE DEPUY SYNTHES COMPONENTS REMOVED? YES, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440108. LOT NUMBER: MC4462, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 8 LEFT CEMENTED. . CATALOG NUMBER: 150660006, LOT NUMBER: 4986915, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG NUMBER: 151710810, LOT NUMBER: 9927060, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 8 10MM. CATALOG NUMBER: 151214050, LOT NUMBER: D25093258, COMPONENT TYPE: STEM, DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM. CATALOG NUMBER: 545050501, LOT NUMBER: 4989849, COMPONENT TYPE: CEMENT, DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151111203,

  Patient problems: Insufficient Information

  MAUDE report 24430780 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607626 ↗
• InjuryNov 13, 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 KNEE REVISION ¿ ASEPTIC LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 20 OCT 2025, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547683 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REMOVAL TOTAL KNEE DUE TO INFECTION STAGE 1. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23467046 ↗
• InjuryNov 3, 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 REVISION ¿ ASEPTIC LOOSENING DATE OF EVENT: 06 OCT 2025 DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452610 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024 , DOR: (B)(6) 2025 , AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968716 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6) 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED, AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838514 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POSTOPERATIVELY AND FRACTURED AROUND AND DISTAL TO THE TIBIAL COMPONENT. IMPLANTS WERE REMOVED IN AN EFFORT TO BYPASS THE FRACTURE SITE AND ACHIEVE STABLE FIXATION MORE DISTAL IN THE TIBIA. ALL COMPONENTS HAD PERFORMED AS EXPECTED AND NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. MODULAR FEMORAL COMPONENTS WERE REMOVED TO GAIN EXPOSURE AND WERE EXCHANGED AS THE PATIENT HAD A PRIOR HISTORY OF INFECTION. RESORBABLE ANTIBIOTIC BEADS WERE PLACED AS A PRECAUTION ALTHOUGH EVIDENCE OF PERSISTENT INFECTION WAS NOT PRESENT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22740750 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730713 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6) MEDICAL CENTER. CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025,

  Patient problems: Unspecified Infection

  MAUDE report 21884172 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS REVISED DUE TO INFECTION. AN ARTICULATING SPACER AND ANTIBIOTICS WERE PLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21763301 ↗
• InjuryNov 1, 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 INFECTION OF HARDWARE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20587522 ↗
• MalfunctionAug 14, 2024Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INNER PACKAGING HAD BEEN STUCK TO THE OUTER PACKAGING, WHICH CAUSED THE IMPLANT TO BE CONTAMINATED UPON OPENING.

  Patient problems: Insufficient Information

  MAUDE report 19980775 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764525 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PULLED OUT THE FEMUR/POLY/TIBIA/AND PATELLA DUE TO INFECTION. CLEANED OUT THE INFECTED AREA AND CHIPPED AWAY ALL OF THE OLD CEMENT. SURGEON THEN USED ANTIBIOTIC BEADS/CEMENT/A PS FEMUR/AND A CRS POLY AS AN ANTIBIOTIC SPACER TO RID OF THE INFECTION BEFORE THE PATIENT RECEIVES A FULL ATTUNE REVISION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19541602 ↗
• InjuryMay 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID:(B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO TIBIAL LOOSENING. DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: (B)(6) 2024 (RIGHT KNEE) TREATMENT: TIBIAL BASE WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 19251015 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOSS OF FLEXION TO STUDY LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 19187749 ↗
• InjuryApr 24, 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: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19177493 ↗
• InjuryApr 8, 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 PAIN. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058630 ↗
• InjuryMar 22, 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: INFECTION, PAIN & LOOSENING.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 18962061 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND TIBIA WAS FRACTURED. SURGEON REMOVED IMPLANTS AND CABLED TIBIA THEN PROCEEDED TO RE IMPLANT NEW IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18825693 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TOTAL REVISION DUE TO PAIN, STIFFNESS, AND FEMORAL COMPONENT LOOSENING. THE DEBONDING WAS BETWEEN THE BONE AND CEMENT, NOT THE FEMORAL COMPONENT AND CEMENT. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18084605 ↗
• InjuryNov 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  LOOSE ATTUNE REVISION TIBIA WITH A PARTIAL COATED SLEEVE.

  Patient problems: Insufficient Information

  MAUDE report 18074580 ↗