ATTUNE 1516-40-714Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295050261), received between Feb 20, 2018 and Mar 20, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO LOOSENING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16571984 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PROGRESSIVE PAIN AND INSTABILITY IN RIGHT KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16310642 ↗
• InjurySep 16, 2021Use of Device Problem; Device Dislodged or Dislocated; Naturally Worn; Use of Device Problem; Device Dislodged or Dislocated; Naturally Worn

  A PATIENT WAS ADMITTED FOR SURGERY TO REPAIR A DISLOCATED ATTUNE KNEE. IT WAS NOT DISCLOSED HOW LONG THIS PATIENT HAD GONE SINCE PRIMARY KNEE SURGERY. INTRA-OPERATIVELY, THE JOINT CAPSULE WAS GROSSLY SWOLLEN AND EXPELLED COPIOUS AMOUNTS OF FLUID DURING INCISION INTO THE JOINT CAPSULE. IT IS UNCLEAR WHAT INITIATED THE FLUID BUILDUP IN THE JOINT. UPON REACHING THE JOINT-SPACE, IT WAS OBSERVED THAT A ATTUNE SZ 7 PS FB POLY INSERT HAD BECOME INVERTED FOLLOWING ITS DISLOCATION FROM THE FB TIBIAL TRAY IN THE JOINT-SPACE. THE POLY INSERT WAS SEVERELY DEFORMED. THE SURGEONS LOOKED FOR POSSIBLE FRAGMENTS BUT NONE WERE FOUND WITHIN THE JOINT-SPACE TO REMOVE. CULTURES WERE TAKEN FOR POSSIBLE INFECTION. THE KNEE WAS WASHED THOROUGHLY WITH SALINE AND ANTISEPTIC SOLUTION. ANOTHER SIZE 7 PS FB POLY WAS INSERTED IN ITS PLACE. THE SURGEON COMMENTED THAT THIS WAS THE FIRST ATTUNE PS FB INSERT THAT HAD DISSOCIATED FROM THE FB TIBIAL TRAY. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation; Swelling/ Edema

  MAUDE report 12482019 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGEON SUSPECTED A LOOSE FEMUR. INTEROPERATIVELY, THE KNEE DID NOT APPEAR LOOSE TO THE SURGEON. SURGEON SPENT CONSIDERABLE TIME WITH OSTEOTOMES AND MALLET BLOWS TO REMOVE THE FEMUR. FEMUR WAS REPLACED WITH A STEMMED CRS. ATTUNE REVISION AND A NEW PS INSERT. NO INFECTION WAS INDICATED FROM THE INTEROPERATIVE FINDINGS OF THE FROZEN SECTION OR GRAM STAIN. DOI: (B)(6) 2012; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9831176 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RERUPTURE PATELLAR TENDON, SEPTIC ARTHRITIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2018; (LEFT KNEE). TREATMENT: LEFT KNEE REVISED, WITH REMOVAL OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, OFFSET ADAPTOR, AND TIBIAL STEM.

  Patient problems: Unspecified Infection

  MAUDE report 9565639 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO STIFF KNEE. TIBIAL INSERT THICKNESS WAS REDUCED AND KNEE MOBILITY WAS IMPROVED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9489325 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL THAT RESULTED IN A SIGNIFICANT OPEN WOUND ON HER LEFT KNEE. PATIENT HAD TKA ON (B)(6) 2019. IT WAS ALSO REPORTED THAT I&D WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9010068 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MAL-ALIGNMENT.

  Patient problems: No Code Available

  MAUDE report 8039440 ↗
• InjuryFeb 20, 2018Adverse 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) 2017; DOR: (B)(6) 2018; LEFT KNEE. NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 7282051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507