ATTUNE 1513-16-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295043676), received between Feb 11, 2019 and Jun 26, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN ER WITH A TIBIA FRACTURE. WELL FIXED AND WELL FUNCTIONING COMPONENTS IN THE TIBIA WERE REMOVED, CABLES PLACED AND AND A LONGER STEM WAS PLACED PASSING THE FRACTURE. NO DELAY NOR PATIENT HARM WERE NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 25636430 ↗
• InjuryMay 21, 2026Fracture

  IT WAS REPORTED THAT THE FEMORAL STEM BROKE AT THE JUNCTION TO THE FEMORAL SLEEVE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25242575 ↗
• InjuryDec 29, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL COMPONENT LOOSENED AND WAS CAUSING PAIN AND DISCOMFORT IN PATIENTS LEFT KNEE. EVALUATION AND XRAY CONFIRMED DIAGNOSIS. FEMORAL COMPONENT WAS REVISED TO CORRECT PATIENT ISSUE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Inadequate Osseointegration; Pain

  MAUDE report 23908478 ↗
• 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 23467070 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22948111 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22026378 ↗
• 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 21925516 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE, DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET AD

  Patient problems: Insufficient Information

  MAUDE report 21881798 ↗
• InjuryFeb 3, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION DONE IN 2021. THE TIBIAL COMPONENTS BECAME LOOSE AND THE PATIENT WAS BROUGHT IN FOR TIBIAL COMPONENTS REVISION. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21294396 ↗
• 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 20587543 ↗
• 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 20352394 ↗
• 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 20352349 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO SUBSIDENCE OF HER ATTUNE REVISION TIBIAL BASE COMPONENTS. DURING THIS PROCEDURE, TIBIAL INSERT AND TIBIAL BASE COMPONENTS WERE REMOVED. THEY WERE THEN REPLACED BY NEW ATTUNE REVISION COMPONENTS, TO INCLUDE AN ATTUNE REVISION CONE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19350499 ↗
• InjuryJan 25, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT UNKNOWN INTERFACE FROM INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18581557 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE; EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Swelling/ Edema

  MAUDE report 17488325 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE IMPLANTS WERE NOT INGROWN DUE TO THE SHORT DURATION IN THE PATIENT BUT THERE WERE WELL FIXED. THE PERIPROSTHETIC FRACTURE IS AT THE TIBIAL SIDE AND THE FEMORAL SIDE COMPONENTS WERE WELL FIXED AND LEFT IN PLACE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17297130 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED THROUGH THE ER WITH SUSPECTED INFECTION. ASPIRATION CONFIRMED THE INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH DEBRIDEMENT WAS PERFORMED, AND A SPACER AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. TIBIAL COMPONENTS WERE PLACED SOMEWHERE ELSE AT AN UNKNOWN TIME AND LOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17119063 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? --> NO. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> NO. D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> JOINT LINE WAS SET BY PREVIOUS SURGERY. E. PLEASE CLARIFY IF THE PATIENT'S PATELLA HAD ALREADY RESURFACED PRIOR TO THIS REVISION, AND IF SO, WAS THE PATELLA PRODUCT A DEPUY PATELLA IMPLANT? IF IT IS, IT WILL NEED TO BE ADDRESSED FOR JOINT INSTABILITY FOR THE PATELLA TRACKING ISSUES. --> IT HAD AN UNIDENTIFIABLE IMPLANT IN PLACE AND REMAINED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17038545 ↗
• InjuryApr 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY VIA TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS THE POSSIBILITY OF METALLOSIS DUE TO MICRO-MOTION OF THE TAPER LOCK BETWEEN FEMORAL SLEEVE AND FEMORAL COMPONENT. THERE WAS ALSO THE POSSIBILITY OF LOOSENESS DUE TO METALOSIS. THE REVISION SURGERY WAS DONE ON AN UNKNOWN DATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT IT MIGHT BE A LOOSE TAPER LOCK. HE WANT THE INVESTIGATION TO IDENTIFY THE SOURCE OF THE METAL DEBRIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16746649 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED KNEE DUE TO PATIENT DISCOMFORT, HE ALSO FELT THE KNEE WAS UNSTABLE. TIBIA SEEMED TO COME OUT EASIER THAN MOST, NOT SURE IF IT WAS LOOSE OR UNDERSIZED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 15475694 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15443134 ↗
• InjuryAug 10, 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 15198379 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14697977 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688754 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BROKEN RIGHT HIP. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - PLACEMENT OF RIGHT DYNAMIC HIP SCREW ON (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 14370767 ↗