ATTUNE 1517-10-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295055846), received between Jul 7, 2020 and Aug 22, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 22874927 ↗
• InjuryNov 19, 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 THE KNEE. THERE WAS A WASH OUT WITH POLY SWAP. DOI: (B)(6) 2023, DOR:(B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20727161 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19270431 ↗
• InjuryJan 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS TYING HER SHOES AND FELT A POP. XRAYS SHOWED THE POST HAD ESCAPED ANTERIORLY TO THE FEMUR. WHEN THE INCISION WAS PERFORMED IT WAS NOTED THAT THE PATIENT HAD RUPTURED THE CAPSULAR REPAIR. A POLY EXCHANGE WAS PERFORMED UNEVENTFULLY TO A THICKER INSERT AS IT APPEARED THAT SHE HAD STRETCHED OUT OVER TIME. ALL COMPONENTS WERE WELL FIXED AND APPROPRIATELY PLACED AND SIZED. THE JOINT LINE WAS APPROPRIATE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 18425476 ↗
• InjuryMar 28, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY VIA TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS THE POSSIBILITY OF METALLOSIS DUE TO MICRO-MOTION OF THE TAPER LOCK BETWEEN FEMORAL SLEEVE AND FEMORAL COMPONENT. THERE WAS ALSO THE POSSIBILITY OF LOOSENESS DUE TO METALOSIS. THE REVISION SURGERY WAS DONE ON AN UNKNOWN DATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT IT MIGHT BE A LOOSE TAPER LOCK.

  Patient problems: Foreign Body Reaction

  MAUDE report 16627711 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS. NEW INSERT IMPLANTED. NO SURGICAL DELAY WAS THERE AND NO FURTHER WAS INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 15966317 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE WAS DONE DUE TO INSTABILITY. NO ADDITIONAL INFORMATION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14696896 ↗
• InjuryFeb 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE FEMORAL COMPONENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. ATTUNE CRS FEMORAL CONSTRUCT WAS REMOVED AND REPLACED WITH AN SROM HINGE FEMORAL COMPONENT AND CEMENTED STEM AND SLEEVE. MOST RECENT DISLOCATION WAS SUSTAINED DURING THE PATIENT FALLING. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 13533618 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR:(B)(6) 2021. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11969178 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVAL OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507315 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INSTABILITY OF LATERAL LIGAMENTS. ON (B)(6) 2020, THESE REVISION IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANTS FROM ANOTHER COMPANY. SIDE: LEFT.

  Patient problems: No Code Available

  MAUDE report 10242089 ↗