ATTUNE 1512-16-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295043010), received between Dec 2, 2019 and Apr 7, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 1, 2021Terminated

   Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

   Z-2348-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 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: (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: ATTUNE KNEE SYSTEM REVI

  Patient problems: Limb Fracture

  MAUDE report 24802139 ↗
• InjuryOct 23, 2025Adverse 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 POST-OPERATIVE ANEMIA. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15 FEB 2020. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368201 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CONTINUED PAIN & EFFUSION. FEMORAL REVISION WAS PERFORMED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22876128 ↗
• InjuryJan 13, 2025Adverse 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 THE PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21139448 ↗
• 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 20587562 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION SO DOCTOR PULLED ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18335967 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3RD REVISION. ATTUNE REVISION FEMUR LOSENING. PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-01589849. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589850. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589851. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589852. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589853. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589854. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01589855. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16087399 ↗
• InjuryApr 11, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE (RIGHT) - CONFIRMATION OF LOOSENING TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION OF KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14073467 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE - AS A RESULT OF RAISED CRP AND INFECTION - CONFIRMATION OF LOOSENING TIBIAL COMPONENT? UNCONFIRMED CURRENTLY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: ARTHROSCOPY, ARTHROSCOPIC BIOPSIES TO CONFIRM INFECTED TOTAL KNEE; ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 13939575 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SLID OUT OF A WHEELCHAIR AND SUFFERED A PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION OF FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 13117319 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND INSTABILITY, SUBJECTIVELY WORSE ON STAIRS WEAKNESS SUPPORTING KNEE AND HIP MUSCLES. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12690989 ↗
• MalfunctionJun 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 5 TO 10 MINUTE SURGICAL DELAY. IT WAS THE RIGHT SIDE THAT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982554 ↗
• MalfunctionJun 11, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A 5 TO 10 MINUTE SURGICAL DELAY. IT WAS THE RIGHT SIDE THAT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982546 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION AS A CONSEQUENCE OF PERIPROSTHETIC JOINT INFECTION; SEPTIC MULTI ORGAN FAILURE DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION OF THE LEFT KNEE AND EMPYEMA OF THE RIGHT KNEE AND LEFT SHOULDER. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE).

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10831724 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10104212 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE PAIN POST TKR REVISION AT TIBIA AND INFLAMMATION OF ITB AT GERDY'S TUBERCLE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. . EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019 (ONSET); (RIGHT KNEE).

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9396832 ↗