ATTUNE 1506-40-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295042792), received between Sep 16, 2019 and Sep 30, 2026 — classified as 29 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K160700, K241000); they may or may not involve this specific model.

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 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was infected, doctor removed all components.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50947383 ↗
• 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 50226293 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WITH AUGMENTS, POLY AND FEMUR WERE ALL REMOVED DUE TO INSTABILITY. ALL PIECES WERE REMOVED FROM THE PT. AND THE FIELD IMMEDIATELY IN THEIR ENTIRETY AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION. AFFECTED SIDE- RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24896556 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE DEVICE AND PROCEDURE. (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2022 DATE OF IMPLANT: (B)(6) 2017 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT TREATMENT/IMPACT: INJECTED MEDICATION: YES.

  Patient problems: Pain

  MAUDE report 24459488 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24366325 ↗
• InjuryJan 7, 2026Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. TIBIA SUBSIDED. PATIENT OUTCOME IS REPORTED AS GOOD. DOI- (B)(6) 2020. DOR- (B)(6) 2025. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23993029 ↗
• InjuryFeb 3, 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 EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE DEVICE AND PROCEDURE(RELATEDNESS) RELATEDNESS TO DEVICE: POSSIBLY RELATEDNESS TO PROCEDURE: POSSIBLY DATE OF EVENT: UN OCT 2023 DATE OF IMPLANT: (B)(6) 2020 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295843 ↗
• 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 A UTI ROUGHLY ONE MONTH AGO, AND THE SURGEON BELIEVES IT SEEDED HER TOTAL KNEE AS THE PATIENT HAD BEEN DOING QUITE WELL PRIOR TO THIS EVENT. ALL WELL FIXED, WELL ALIGNED AND WELL FUNCTIONING IMPLANTS WERE REMOVED AND REVISED IN A ONE STAGE REVISION KNEE FOR INFECTION. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21149593 ↗
• InjuryNov 1, 2024Adverse 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 ENTRAPMENT RAMUS INFRAPATELLARIS DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK (B)(6) 2020, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: ON (B)(6) 2019, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 20590601 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). 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 20534570 ↗
• InjuryOct 17, 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 RIGHT KNEE ARTHROFIBROSIS. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: (B)(6) 2019. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 20471447 ↗
• 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: DID SUBJECT REPORT ANY NEW AES OR ANY UPDATES TO AN EXISTING AE AT THIS EVALUATION? : YES. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: KNEE; NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO REMOVAL/EXCHANGE/REVISION. ADDITIONAL EVENT INFORMATION. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT KNEE. TREATMENT/IMPACT: ASPIRATION/DRAINAGE; RECOVERED/RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2019.

  Patient problems: Swelling/ Edema

  MAUDE report 20332931 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE EFFUSION: DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 29 OCT 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: BLANK. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 20293189 ↗
• InjuryAug 22, 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. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20030117 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19324654 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: UNK OCT 2023. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825506 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS EXPLANTED DUE TO EXPECTED INFECTION. DOI:(B)(6), 2023. DOR: (B)(6), 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18476264 ↗
• InjuryNov 16, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIA COMP BECAUSE OF SUBSIDENCE AND PATELLA. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18148865 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION, ALL IMPLANTS WERE TAKEN OUT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17051901 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16709013 ↗
• InjuryDec 21, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16023238 ↗
• InjuryDec 15, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  VOLUNTARY REPORT RECEIVED (B)(4) "KNEE TOTAL ARTHROPLASTY. TIBIAL COMPONENT WAS GROSSLY LOOSE. APPEARED DEFECTIVE. PIN SHEARED WITH NO THREADS AND STEM BROKEN OFF. IMPLANTED (B)(6) 2020, REMOVED AND REPLACED (B)(6) 2022. FDA SAFETY REPORT ID (B)(4)."

  Patient problems: Insufficient Information

  MAUDE report 15987096 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MID TO DISTAL ANTERIOR THIGH PAIN ON (B)(6) 2017, THE PATIENT HAD A REVISED TOTAL RIGHT KNEE TO ADDRESS INSTABILITY. DEPUY COMPONENTS ALONG WITH COMPETITOR CEMENT X2, WERE IMPLANTED DURING THIS PROCEDURE.. (B)(6) 2019 MEDICAL RECORDS NOTE THAT THE PATIENT PRESENTS WITH PAIN IN RIGHT KNEE AND HIP, WITH BUCKLING AND SWELLING OF THE RIGHT KNEE. LEFT KNEE PAIN DUE TO OA CHANGES (NATURAL KNEE). PATIENT IS DOING PHYSICAL THERAPY DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2018. (RIGHT KNEE) TREATMENT: PHYSICAL THERAPY.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 11992849 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2018, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY & KNEE BRACE.

  Patient problems: Joint Laxity

  MAUDE report 11885685 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11013118 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160700, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0631-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
• Z-0632-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
• Z-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee