ATTUNE 1516-40-614Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295050124), received between Oct 1, 2018 and Mar 10, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 18, 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 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24560416 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS PLAYING PICKLE BALL WHEN PATIENT FELT DISCOMFORT AND PAIN IN KNEE. PATIENT DESCRIBED KNEE FEELING STUCK, BUT AFTER SOME TIME PATIENT WAS ABLE TO MOVE KNEE NORMALLY. DISCOMFORT CONTINUED LEADING PATIENT TO SEE A DOCTOR FOR KNEE. SURGEON FOUND THAT THERE WAS SOME RESISTANCE WHEN MOVING THE KNEE AS WELL AS SLIGHT LAXITY. POLY EXCHANGE WAS PERFORMED TO CORRECT PROBLEM. SURGEON FOUND SCAR TISSUE WITHIN THAT NOTCH OF THE PS FEMUR THAT WAS CATCHING THE PS POST WITHIN THE NOTCH. SURGEON REMOVED SCAR TISSUE AND TRIALED PS POLY'S AND DETERMINED A THICKER POLY WAS NOW NEEDED DUE TO THE LAXITY OF THE JOINT. DOI: UNKNOWN. DOE: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 24469350 ↗
• InjuryNov 7, 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 INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23496859 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO LIGAMENT LOOSENING FOLLOWING FALL. NO ADDITIONAL INFORMATION. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 15594708 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL AND INCISION OPENED. THE SURGEON SWITCHED POLY INSERT. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15445698 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THIS PATIENT HAD BILATERAL ATTUNED. THE RIGHT TIBIA WAS REVISED PREVIOUSLY. MDR DONE FOR THAT REVISION AS WELL. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); Joint Disorder; No Code Available; Pain

  MAUDE report 10516378 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED LOOSE ATTUNE TRAY (B)(6) 2019 - REPLACED WITH STEMMED TIBIA AND CAPTURED IN (B)(4). IT WAS ALSO REPORTED THAT THE PATIENT IS MISERABLE WANTED ALL COMPONENTS REMOVED. THEY PLANNED A TC3 RP. FEMORAL COMPONENT IN TOO MUCH VALGUS. PATELLA, FEMUR, POLY AND TIBIA WERE REMOVED. TC3 CP - RESULT LESS VALGUS - BALNCED WELL, PATELLA TRACKED WELL. THERE WAS A SURGICAL DELAY OF 80 MINS. DOI: (B)(6) 2019 (TIBIAL TRAY, INSERT AND PRESSFIT STEM); (B)(6) 2018 (PATELLA AND FEMORAL); DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9818131 ↗
• InjuryNov 1, 2018Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8027992 ↗
• MalfunctionOct 1, 2018Off-Label Use; Off-Label Use

  DER STATES THAT AN EXPIRED TIBIAL INSERT WAS IMPLANTED IN THE PATIENT. DURING SURGERY, AN EXPIRED IMPLANT WAS OPENED ON THE FIELD. PRIOR TO IMPLANTING, THE SITUATION WAS DISCOVERED AND THE DOCTOR WAS MADE AWARE. SINCE IT WAS THE ONLY INSERT OF THE SELECTED SIZE AT THE HOSPITAL, THE SURGEON DECIDED TO IMPLANT THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922938 ↗

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