ATTUNE 1511-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295436522), received between May 30, 2019 and Sep 17, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239528 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: BLANK ALERT DATE: 28-JUN-2019 COUNTRY OF EVENT: OUS PROCEDURE: TYPE OF REVISION - OPERATIVE DETAILS PART 1: FULL PROCEDURE: KNEE REVISION USING ATTUNE - OPERATIVE DETAILS PART 2: PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019 EVENT DESCRIPTION (DIAGNOSIS): OPERATIVE WOUND DEHISCED CENTRAL 8CMS: FURTHER REVISION SURGERY REQUIRED. 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: 26 JUN 2019 (LEFT KNEE) TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19645936 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA TENDON RUPTURE AND INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: RECONSTRUCTION OF PATELLA TENDON, I&D, INJECTED MEDICATION, AND REPEATED DAIR PROCEDURES

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19133203 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION DEFICIT AT RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2023; (RIGHT KNEE) . TREATMENT: DIAGNOSTIC INTERVENTION AND RESECTION OF HETEROTOPIC BONE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19117291 ↗
• InjuryJan 16, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT HAD BEEN DOING WELL POST SPACER. BEGAN HAVING PAIN A FEW DAYS PRIOR TO STATED SURGERY DATE. XRAYS WERE UNREMARKABLE. PATIENT TAKEN TO OR AND FOUND THAT THE FEMORAL SLEEVE HAD BECOME LOOSE. IN THE PROCESS OF SEPARATION AND REMOVAL, THE TIBIAL SIDE WAS ALSO REMOVED. A THOROUGH DEBRIDEMENT AND IRRIGATION WAS PERFORMED. FEMUR AND TIBIA WERE THEN PREPARED FOR A NEW SPACER UNEVENTFULLY AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED ALONG WITH THE NEW SPACER. NO PATIENT HARM OCCURRED. NO DELAY WAS EXPERIENCED. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 18517697 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF TOTAL KNEE TO ADDRESS LOOSE FEMUR EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): 03/01/2022. (RIGHT KNEE). TREATMENT: REVISION OF FEMORAL CONSTRUCT.

  Patient problems: Insufficient Information

  MAUDE report 14799624 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND LOOSENING. IT IS UNKNOWN WHICH PRODUCTS AND INTERFACES WERE LOOSE.

  Patient problems: Pain

  MAUDE report 13791985 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: 2 X ERYTHROCYTE CONCENTRATE (TRANSFUSION 2 UNITS PACKED RED BLOOD CELLS).

  Patient problems: Anemia

  MAUDE report 11263882 ↗
• MalfunctionJun 2, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSE FEMORAL SLEEVE : MIGRATION/LOOSENING - FEMORAL. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10109042 ↗
• 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 9972162 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Anemia; Discomfort; Pain

  MAUDE report 9450915 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BECAUSE THE PATIENT HAD EXTREMELY THIN FEMORAL CORTICES PROF (B)(6) CEMENTED THE TIBIAL COMPONENT IN SEPARATELY TO THE FEMORAL COMPONENT. THE TIBIAL CEMENTATION WENT WELL. HOWEVER, WHEN PROF (B)(6) IMPLANTED THE DEFINITIVE FEMORAL COMPONENT WITH 50MM FEMORAL SLEEVE THE FEMUR FRACTURED. THE SURGEON REMOVED THE FEMORAL COMPONENT BEFORE THE CEMENT HAD CURED AND UPON INSPECTION OF THE FRACTURE DEEMED IT NECESSARY TO CONVERT TO A LPS DISTAL FEMORAL COMPONENT WHICH HE HAD ON STANDBY FOR THIS SURGERY. UNFORTUNATELY THE ATTUNE REVISION RP TIBIAL COMPONENT WAS EXTREMELY WELL FIXED AND AS THE SURGERY HAD ALREADY TAKEN OVER 3 HOURS THE SURGEON FELT IT UNWISE TO CONTINUE WITH A TIME CONSUMING EXTRACTION OF THE WELL FIXED TIBIAL COMPONENT. HE THEREFORE HAD NO OPTION BUT TO USE AN INCOMPATIBLE LPS INSERT WITH THE LPS FEMUR AND ATTUNE REVISION RP TIBIA.

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

  MAUDE report 8655624 ↗