ATTUNE 1516-50-814Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295052906), received between Jan 17, 2019 and Apr 16, 2024 — classified as 9 injuries.

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.

• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19118144 ↗
• 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 17773210 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BECOME UNSTABLE OVER TIME. POLY WAS EXCHANGED FROM A 14MM TO A 20MM. NO COMPONENTS WERE PRESENTED AS LOOSE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2016, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15216674 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS (ONGOING). EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 12975469 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TIGHT KNEE, SURGEON EXPLANTED POLY REVISING WITH SMALLER INSERT. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11934764 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THIS PATIENT PRESENTED BACK WITH WHAT THE SURGEON CALLED A LT TKA INFECTION AFTER RECEIVING A POLY SWAP FOR INSTABILITY ON (B)(6) 2020 (REFERENCE MDR CASE NUMBER 156293). THE SURGEON WANTED TO NOW DO AN I&D WASH OUT, AND USE STIMULAN BEADS. THE SURGEON ALSO REMOVED THE POLY, HENCE THE REASON FOR THIS NEW MDR REPORT. THE PATIENT EXPRESSED TO THE SURGEON THAT AFTER THE POLY SWAP FOR INSTABILITY HIS KNEE FELT MUCH BETTER, UNFORTUNATELY THE PATIENT GOT "INFECTED" ACCORDING TO THE SURGEON AND HENCE THE NEED FOR THE NEW POLY EXCHANGE. NO SURGICAL DELAY IS NOTED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10502979 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9868452 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. I & D WITH POLY EXCHANGE. DOI: UNKNOWN; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9384191 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8257542 ↗