ATTUNE 1513-12-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10603295043546), received between Oct 5, 2018 and Aug 3, 2026 — classified as 65 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain.Affected side: Left knee.

  Patient problems: Pain

  MAUDE report 50116853 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24618445 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CRS FEMORAL RT SZ 5 CEM, ATUNE PRESSFIT STR STEM12X60MM, ATTUNE CEMENTED STEM 14X50MM, ATTUNE CRS RP INSRT SZ 5 6MM, ATUNE REV RP TIB BASE SZ 4 CEM, ATUN TIB SLV M/L 29MM HALF POR, AND ATTUNE MEDIAL ANAT PAT 32MM WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A REVISION OF A PREVIOUS ATTUNE REVISION PROCEDURE, WITH THE REASON FOR REVISION BEING INFECTION. THE SURGEON SUSPECTED INFECTION AT THE TIME OF IMPLANTATION DUE TO POOR INGROWTH IN THE TIBIAL SLEEVE AND NOTED THAT THE CEMENTED FEMORAL STEM WAS EASILY REMOVED. THE EVENT WAS ASSOCIATED WITH THE RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23862769 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025, THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607495 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404490 ↗
• 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: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22948035 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6) 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838720 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM; THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TOURNIQUET WAS REMOVED AND THE LEG MOVED POST OP. THE PATIENT WAS TRANSFERRED TO HAVE PLATING COMPLETED TO REPAIR THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22703116 ↗
• InjuryJul 21, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF AN ATTUNE REVISION CONSTRUCT. REASON FOR REVISION DUE TO LOOSENING OF TIBIAL STEM, FEMORAL SLEEVE AND STEM RESULTING IN SUBSIDENCE. NO SIGN OF INFECTION. RIGHT SIDE WAS IMPACTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22554004 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION ON A DISTAL FEMUR DUE TO PATELLA INSTABILITY. PATELLA WAS NATURAL AND WAS NOT RESURFACED OR REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22071120 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 22 NOV 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461666 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMS OF INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH I&D PERFORMED AND A ACER WAS FASHIONED OF LPS COMPONENTS. NO DELAY NOR PATIENT HARM WAS NOTED. ALL COMPONENTS WERE WELL FIXED AND INGROWN. PATIENT DID HAVE A COMPONENT EXCHANGE WITH I&D PERFORMED ON (B)(6) 2024 DUE TO A FALL. (B)(4) WAS FILED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19809579 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT: REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED DOI: (B)(6) 2024; DOE: (B)(6) 2024. ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION. REVISED TO SROM HINGE. PERSISTENT INFECTION. RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19740680 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR LOSS OF FLEXION TO STUDY LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: ON (B)(6) 2023, DATE OF EVENT: 04 MAR 2024, (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 19187750 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19166806 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING TO RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION

  Patient problems: Swelling/ Edema

  MAUDE report 18928747 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. THE PATIENT FELL AND NEEDED LARGER COMPONENTS. 2. NO REPORTED SURGICAL DELAYS.

  Patient problems: Fall; Pain

  MAUDE report 18893245 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Pain

  MAUDE report 18806497 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE WAS EXPLANTED DUE TO INFECTION. NO ONE MENTIONED ANY PROBLEMS WITH OUR IMPLANTS. SURGEON REPLACED WITH ANTIBIOTIC SPACER. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18697520 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Infection

  MAUDE report 18697518 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 17773225 ↗
• InjuryAug 15, 2023Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED: PLEASE CONFIRM THE REASON FOR THE CABLE WITH A CABLE SLEEVE WAS IMPLANTED. WAS THERE A FRACTURE THAT OCCURRED DURING THE IMPLANTATION OF THE IPS FEMORAL CONSTRUCT? THE CABLE IS USED TO PREVENT A FRACTURE FROM OCCURRING. IT IS USED IN 100% OF THE SURGEONS' CASES TO AVOID CATASTROPHIC FAILURE FROM BROACHING, IMPLANTATION, OR LOADING OF THE CONSTRUCT WHILE INGROWTH TAKES PLACE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain

  MAUDE report 17549574 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PROVIDED ADDITIONAL INFORMATION VIA EMAIL STATING "YES IT IS MY 2019 KNEE REPLACEMENT THAT HAS COME LOOSE. I AM SCHEDULED FOR RIGHT KNEE REPLACEMENT SURGERY IN OCT. X-RAYS HAVE SHOWN THE FEMORAL PART IS DEFINITELY LOOSE AND IS CAUSING PAIN AND I HAVE PROBLEMS WALKING. PLEASE LET ME KNOW WHEN YOU FIND OUT IF RECALLED AND WHAT CAN BE DONE.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Pain; Swelling/ Edema

  MAUDE report 17216564 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT REMOVAL OF NEUROMA WAS USED AS A TREATMENT FOR THE ADVERSE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17192005 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXCISION SCAR NEUROMA RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17191951 ↗