ATTUNE 1549-05-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295383062), received between Dec 10, 2019 and Apr 7, 2026 — classified as 41 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FRACTURE (MEDIAL FEMORAL CONDYLE). DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 01 MAR 2018. DATE OF IMPLANT: ON (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE: YES. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 66017569. LOT NUMBER: 87094695. COMPONENT TYPE: CEMENT. DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: 150440205. LOT NUMBER: HC1433. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED RIGHT SIZE 5. CATALOG NUMBER: 151216080. LOT NUMBER: H44164. COMPONENT TYPE: FEMORAL STEM. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CEMENTED STEM 16X80MM. CATALOG NUMBER: 151820038. LOT NUMBER: 8695634. COMPONENT TYPE: PATELLA. DESCRIPTION: ATTUNE PATELLA MEDIALIZED DOME 38MM CEMENTED AOX. CATALOG NUMBER: 150640004. LOT NUMBER: 8641298. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION FIXED BEARING TIBIAL BASE CEMENTED SIZE 4. CATALOG NUMBER: 151700512. LOT NUMBER: H66856. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPT

  Patient problems: Limb Fracture

  MAUDE report 24802057 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FRACTURE (MEDIAL FEMORAL CONDYLE). DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 01 MAR 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NONE: YES. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 66017569. LOT NUMBER: 87094695. COMPONENT TYPE: CEMENT. DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: 150440205. LOT NUMBER: HC1433. COMPONENT TYPE: FEMORAL COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED RIGHT SIZE 5. CATALOG NUMBER: 151216080. LOT NUMBER: H44164. COMPONENT TYPE: FEMORAL STEM. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CEMENTED STEM 16X80MM. CATALOG NUMBER: 151820038. LOT NUMBER: 8695634. COMPONENT TYPE: PATELLA. DESCRIPTION: ATTUNE PATELLA MEDIALIZED DOME 38MM CEMENTED AOX. CATALOG NUMBER: 150640004. LOT NUMBER: 8641298. COMPONENT TYPE: TIBIAL BASE COMPONENT. DESCRIPTION: ATTUNE KNEE SYSTEM REVISION FIXED BEARING TIBIAL BASE CEMENTED SIZE 4. CATALOG NUMBER: 151700512. LOT NUMBER: H66856. COMPONENT TYPE: TIBIAL INSERT COMPONENT. DESCRIPTION

  Patient problems: Limb Fracture

  MAUDE report 24802005 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF AN ATTUNE DUE TO LOOSE FEMORAL AND TIBIAL COMPONENTS. THE SURGEON NOTED FIBROUS TISSUE UP THE FEMORAL CANAL AROUND THE FEMORAL STEM CAUSING LOOSENING. THE TIBIAL COMPONENT WAS LOOSE AS IT APPEARED THAT THE SURGEON HAD CEMENTED IN THE CEMENTLESS TIBIAL SLEEVE. RESULTING IN NO BONE INGROWTH. THE PATELLA COMPONENT WAS RETAINED FROM PREVIOUS PRIMARY TKR. THE LOOSENING WAS BETWEEN THE IMPLANT AND BONE INTERFACES. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fibrosis

  MAUDE report 23958207 ↗
• InjuryDec 23, 2025Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: UN JAN 2025, DATE OF IMPLANT: ON (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT, TREATMENT/IMPACT: OTHER: TRUE, IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY ON (B)(6) 2026.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880538 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE IN 2023; THERE WAS A PROXIMAL STRUT ALLOGRAFT PUT ON AT SOME POINT AFTER THE REVISION. THE PATIENT HAD PROXIMAL FEMOR PAIN, THE BONE SCAN SHOWED LOOSENING. A REVISION WAS PLANNED. KNOCKED THE SIZE 5 FEMOR OFF, THERE WAS NO LOOSENING OF OUR FEMORAL SLEEVES OR TIBIAL IMPLANTS. THE ALLOGRAFT WAS LOOSE, AND CABLES WERE LOOSE. THE SURGEON DECIDED TO RETRO FIT A NEW CRS REVISION SIZE 5 LEFT FEMORAL COMPONENT BACK INTO THE WELL INGROWN SLEEVE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23879864 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: NO => YES.

  Patient problems: Pain

  MAUDE report 23554309 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526851 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526845 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL-FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: ON (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT: (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED ON (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011416 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH WAS OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011414 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853639 ↗
• 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 21547927 ↗
• 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 21547732 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20051740 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(4). PATIENT IDENTIFIER: (B)(6). UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR OPERATIVE WOUND DEHISCED CENTRAL 8CMS : WOUND DEHISCENCE REQUIRING DAIR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (LEFT KNEE). TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19664303 ↗
• MalfunctionMar 11, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FEMORAL ACCESSORY IS NOT FIXED WITH TIBIA PLATE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873666 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES

  Patient problems: Unspecified Infection

  MAUDE report 18713444 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO A KNEE INFECTION. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17401056 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 17060459 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 22, WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 22, FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON THE (B)(6) 23.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037475 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO DELAY WAS REPORTED. B. HOW IS THE PATIENT NOW? THE PATIENT IS DOING WELL ACCORDING TO THE SURGEON. C. WERE THERE ANY PATIENT CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE DISLOCATION? JOINT/LIGAMENT LAXITY, PROGRESSION OF THE DISEASE, ETC. UNCLEAR. THE SURGEON STATED THAT HER COLLATERALS HAD BECOME LAX OVER TIME. CAUSE UNKNOWN. D. WAS THERE ANY SUGGESTION THAT THE ATTUNE REVISION PRODUCTS MAY HAVE BEEN OVERSIZED AT PRIMARY? NO. E. WHAT CAUSED THE FRACTURE? WAS IT A RESULT OF THE DISLOCATION? OR DID THE PATIENT HAVE A FALL? THE SURGEON BELIEVES THERE MAY HAVE BEEN A SMALL NONDISPLACED FRACTURE DURING FEMORAL METAPHYSEAL SLEEVE REMOVAL WHICH THEN EXPANDED DURING THE INSERTION OF THE SROM METAPHYSEAL SLEEVE CONSTRUCT. F. YOU MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD ATTUNE REVISION COMPONENTS IN SITU. HAS THE PATIENT UNDERGONE A PRIOR REVISION OF DEPUY PRODUCTS? IF YES, WAS IT REPORTED? (PROVIDE PC# IF POSSIBLE). OR WAS THE PATIENT'S PRIMARY CONSTRUCT NON-DEPUY? NON-DEPUY PRODUCT AT INDEX SURGERY.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 16407275 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15264827 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15264825 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, ON (B)(6) 2022, ALL THE IMPLANTS WERE REMOVED. AT FIRST, THE SURGEON PLANNED TO REMOVE THE INSERT, REPLACED AND CLEANSED; HOWEVER, THE IMPLANTS WERE LOOSENED. CONSEQUENTLY, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED CEMENT MOLD. ACCORDING TO THE SURGEON, THE PATIENT HAD DIABETES AND WAS NOT WELL CONTROLLED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15113118 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR:(B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14753164 ↗