ATTUNE 1547-06-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295382782), received between Dec 11, 2019 and Apr 29, 2025 — classified as 26 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 27 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO NON-CEMENTED LOOSENING OF THE FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21925483 ↗
• InjuryApr 29, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO NON-CEMENTED LOOSENING OF THE FEMORAL COMPONENT. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21925464 ↗
• 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 21764015 ↗
• 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 21763949 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352302 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AFTER THE PATELLA TENDON RUPTURE. NO DELAY PATELLA IS AN IMPLANT AND NOT REMOVED. INSTABILITY NOT RELATED TO POLY WEAR. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18981179 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXCISION SCAR NEUROMA RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17191955 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. 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) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION (UNSPECIFIED).

  Patient problems: Pain

  MAUDE report 16762757 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE REVISION REMOVAL DUE TO A POST OP FIXED FLEXION DEFORMITY FROM THE ORIGINAL REVISION SURGERY ON THE (B)(6) 2021 WITH A FOLLOWING SURGERY FOR A POLY REVISION ALSO DONE ON (B)(6) 2022 TO SEE IF WE DOWNSIZED THE POLY IF THAT WOULD HELP THE DEFORMITY. PATIENT WAS VERY UNHAPPY (ALSO NOT A COMPLIANT PATIENT WITH POST OP RECOVERY).

  Patient problems: Loss of Range of Motion

  MAUDE report 15994880 ↗
• InjuryNov 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15769616 ↗
• InjuryNov 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15769611 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE PATIENT DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14173915 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REVISED THE PATIENT DUE TO INFECTION. SURGEON REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14159755 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID REVISION SURGERY ON (B)(6) 2019 AT CHA. THE KNEE IS NOW INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN AN ANTIBIOTIC KNEE SPACER. DOI: (B)(6) 2019 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12496671 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID REVISION SURGERY ON (B)(6) 2019 AT CHA. THE KNEE IS NOW INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN AN ANTIBIOTIC KNEE SPACER. DOI: (B)(6) 2019 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12496600 ↗
• MalfunctionFeb 26, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE THAT WAS INFECTED. THE INFECTION IS GONE, SO THE TEMPORARY PARTS WERE REMOVED AND DEFINITIVE COMPONENTS WERE IMPLANTED. DURING IMPACTION OF THE FINAL FEMORAL CONSTRUCT, THE IMPLANT WOULD NOT SEAT FULLY. IT WAS A FULL CENTIMETER PROUD. THE SURGEON REMOVED THE FEMUR AND ALL THE CEMENT ON ITS BACKSIDE. THE TRIAL CONSTRUCT SAT PERFECTLY WITH NO ISSUES. THE ASSEMBLY AND SIZES OF ALL PIECES WERE CHECKED AGAIN AND WERE CORRECT. THE SURGEON THEN REBROACHED AND REAMED OVER AND OVER AGAIN. HE USED THE REAL IMPLANT AS THE TEST AND WOULD IMPACT IT BACK IN. HE WOULD GO BACK TO BROACHING AND REAMING, AND SEATING THE REAL IMPLANT. THE IMPLANT WOULD SLOWLY SEAT FURTHER AFTER MORE BACK AND FORTH OF BROACHING AND REAMING. THE SURGEON WAS OVER REAMING THE CANAL BY 1MM. THE 35MM BROACH WAS SEATED 1CM DEEPER THAN IT WAS SUPPOSED TO BE SEATED. AT THIS POINT THE REAL IMPLANT SEATED FULLY. CEMENT WAS REMIXED AND THE REAL IMPLANT WAS INSERTED. ON POST-OP FILMS THE CONSTRUCT LOOKS TIGHT WITH NO EVIDENCE THAT THE BROACH HAD TO BE SEATED A FULL CENTIMETER DEEPER THAN IT WAS SUPPOSED TO BE. THE REBROACHING AND REREAMING MADE IT POSSIBLE FOR THE IMPLANT TO

  Patient problems: Insufficient Information

  MAUDE report 11388426 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. A COMPETITOR CEMENT WAS USED. INTERNAL LEFT KNEE PROSTHESIS WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11114294 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. A COMPETITOR CEMENT WAS USED. INTERNAL LEFT KNEE PROSTHESIS WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11114244 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10401800 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION IN HIS KNEE, ALL IMPLANTS REMOVED, SURGEON STATED THE INFECTION WAS THE SAME BUG THAT REQUIRED HIS PRIMARY IMPLANTS TO BE REMOVED IN THE FIRST PLACE. UNSURE IF THE IMPLANTS REMOVED FROM THE PRIMARY WERE OURS WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> INFECTION REASON FOR THIS REVISION. IT WAS THE SAME ORIGINAL BUG THE PATIENT HAD WHEN HIS FIRST IMPLANT WAS REVISED., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9972170 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTION IN HIS KNEE, ALL IMPLANTS REMOVED, SURGEON STATED THE INFECTION WAS THE SAME BUG THAT REQUIRED HIS PRIMARY IMPLANTS TO BE REMOVED IN THE FIRST PLACE. UNSURE IF THE IMPLANTS REMOVED FROM THE PRIMARY WERE OURS WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> INFECTION REASON FOR THIS REVISION. IT WAS THE SAME ORIGINAL BUG THE PATIENT HAD WHEN HIS FIRST IMPLANT WAS REVISED., WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9972165 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. THE PATIENT CAME IN WITH AN INFECTED TOTAL KNEE. THE PRIOR IMPLANTS WERE ALSO A SECOND STAGE OF AN INFECTED KNEE. THE IMPLANTS WERE REMOVED AND A SPACER WAS PLACED IN THE KNEE. THE DEPUY IMPLANTS PERFORMED PERFECTLY. DOI: (B)(6) 2018; DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9901652 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. THE PATIENT CAME IN WITH AN INFECTED TOTAL KNEE. THE PRIOR IMPLANTS WERE ALSO A SECOND STAGE OF AN INFECTED KNEE. THE IMPLANTS WERE REMOVED AND A SPACER WAS PLACED IN THE KNEE. THE DEPUY IMPLANTS PERFORMED PERFECTLY. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9901651 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SPLIT OF ANTERIOR FEMUR : BONE FRACTURE - FEMORAL (INTRAOPERATIVE, RE-IMPLANTATION). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE). DEPUY COMPONENTS IMPLANTED (B)(6) 2019: CATALOG ID: 151710622. LOT: 8613688. DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 6 22 MM. CATALOG ID: 154706002. LOT: HZ2103. DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154706002. LOT: HZ2103. DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154906002. LOT: J36Y75. DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SIZE 6 8 MM. CATALOG ID: 150660006. LOT: 9213508. DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG ID: 150440106. LOT: J5753J. DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG ID: 151111202. LOT: J35W45. DESCRIPTION: ATTUNE REVISION TIBIAL SLEEVE POROCOAT FULLY COATED 37 MM. CATALOG ID: 154905001. LOT: J2401D. DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SIZE 5 4MM. CATALOG ID

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9557540 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SPLIT OF ANTERIOR FEMUR : BONE FRACTURE - FEMORAL (INTRAOPERATIVE, RE-IMPLANTATION). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE). DEPUY COMPONENTS IMPLANTED (B)(6) 2019: CATALOG ID: 151710622, LOT: 8613688, DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 6 22 MM. CATALOG ID: 154706002, LOT: HZ2103, DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154706002, LOT: HZ2103, DESCRIPTION: ATTUNE REVISION DISTAL FEMORAL AUGMENT SIZE 6 8MM. CATALOG ID: 154906002, LOT: J36Y75, DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SIZE 6 8 MM. CATALOG ID: 150660006, LOT: 9213508, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG ID: 150440106, LOT: J5753J, DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 LEFT CEMENTED. CATALOG ID: 151111202, LOT: J35W45, DESCRIPTION: ATTUNE REVISION TIBIAL SLEEVE POROCOAT FULLY COATED 37 MM. CATALOG ID: 154905001, LOT: J2401D, DESCRIPTION: ATTUNE REVISION POSTERIOR FEMORAL AUGME

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9557534 ↗