ATTUNE 1512-14-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295475156), received between Nov 1, 2018 and Aug 12, 2026 — classified as 54 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient originally had a Uni conversion total Knee. Due to Poor bone quality, a revision was performed with increased fixation using a stem, augment, and cone.DOIL Unknown.DOR: (b)(6) 2026.Affected side: Right.

  Patient problems: Bone Notching

  MAUDE report 50226298 ↗
• 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 25448508 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF RIGHT KNEE PAIN S/P RIGHT TKR. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24958158 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AND ALL COMPONENTS AND CEMENT WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24590734 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE OCCURRED DUE TO INFECTION. ORIGINAL SURGERY WAS DONE ABOUT TWO YEARS AGO. EXACT DATE UNKNOWN. RIGHT SIDE. COMPONENTS WERE WELL FIXED. ALL COMPONENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 24167131 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051353 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051344 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6)2021. DATE OF EVENT: 01 DEC 2021. (LEFT KNEE). TREATMENT: ORAL MEDICATION AND DIAGNOSTIC INTERVENTION. TREATMENT/IMPACT: INJECTED MEDICATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): DEVICE LOG FORM LOG LINE: 1 COMPONENT TYPE: FEMORAL COMPONENT. CATALOG NUMBER: 150440103. LOT NUMBER ID: JC2497. DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 2. COMPONENT TYPE: TIBIAL BASE COMPONENT. CATALOG NUMBER: 150640003. LOT NUMBER ID: 9773729. DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 3. COMPONENT TYPE: TIBIAL STEM. CATALOG NUMBER: 151214030. LOT NUMBER ID: D21063066. DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 4. COMPONENT TYPE: TIBIAL INSERT COMPONENT. CATALOG NUMBER: 151700312. LOT NUMBER ID: J03P07. DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 5. COMPONENT TYPE: CEMENT. CATALOG NUMBER: 66017750. LOT NUMBER ID: 97671012. DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 6. COMPONENT TYPE: CEMENT. CATALOG NUMBER: 66017750. LO

  Patient problems: Pain

  MAUDE report 23310030 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DRAINAGE SUGGESTING HE WAS STILL INFECTED. ALL WELL FIXED, WELL ALIGNED COMPONENTS WERE REMOVED. A THOROUGH DEBRIDEMENT WAS PERFORMED. BONE WAS THEN PREPARED FOR NEW IMPLANTS WHICH ARE PLACED WITH HIGH DOSE ANTIBIOTIC CEMENT ALONG WITH RESORBABLE BEADS THAT CONTAINED BOTH ANTIFUNGAL AND ANTIBIOTICS. NO DELAY WAS NOTED. PREVIOUS CEMENT WAS DEPUY 2 WITH GENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23099809 ↗
• 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: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22967995 ↗
• 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: 10603295383048 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 ADAPTOR DEVICE IDENTIF

  Patient problems: Insufficient Information

  MAUDE report 21882207 ↗
• 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 21764227 ↗
• 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 21763680 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL (TKA) TOTAL KNEE ARTHROPLASTY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21154184 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: HOSPITALIZATION (INITIAL OR PROLONGED): YES => NO. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO => YES.

  Patient problems: Abscess

  MAUDE report 20831775 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). STUDY NO: DSJ_2016_02. CLINICAL ADVERSE EVENTS RECEIVED FOR INSTABILITY. DATE OF EVENT: 24 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION AND CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Laxity

  MAUDE report 20534626 ↗
• InjurySep 30, 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 SEPSIS. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK (B)(6) 2024, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333270 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND UNSTABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20279646 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4). THIS CASE LOGGED TO CAPTURE THE FIRST STAGE REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19960726 ↗
• InjuryFeb 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LIMITED ROM 60-30-0 TARGET KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. 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 18637008 ↗
• InjuryNov 27, 2023Adverse 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 KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: 16 MAY 2021. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, DIAGNOSTIC INVENTION.

  Patient problems: Pain

  MAUDE report 18209053 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO HINGE DUE TO STIFFNESS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17957422 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION AND PHYSICAL THERAPY, NO REVISION COMPLETED.

  Patient problems: Pain

  MAUDE report 17797656 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT FELL AND HAD A PERIPROSTHETIC FEMORAL IMPLANT FRACTURE. THE REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE TO FIX THE AFFECTED AREA WITH PLATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17574517 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRODUCTS WERE EXPLANTED DUE TO INFECTION TO THE RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17540290 ↗