ATTUNE 252303201Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295437239), received between Aug 5, 2019 and Jun 19, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED DURING THE WORKSHOPS, THERE WERE MANY DIFFICULTIES IN MATING THE FB TEST TIBIAL BASES WITH THE LL/MR WEDGE TESTS. FOR EXAMPLE, IN SOME CASES IT IS IMPOSSIBLE TO GET THE WEDGE TO BE 100% FIXED TO THE TIBIAL TEST, LEAVING IT SLIGHTLY LOOSE WITH A LIGHT BETWEEN BOTH COMPONENTS. IN OTHER CASES, THE WEDGE SCREW WAS FUSED TO THE TIBIAL BASE, MAKING IT IMPOSSIBLE TO DISENGAGE THEM. AT FIRST WE SUSPECTED THAT SOME OF THE PARTICIPANTS WERE BEING "ROUGH" WITH THE MATERIALS. HOWEVER, WE DID THE TEST, AND EVEN THOUGH WE WERE VERY CAREFUL, THE SAME THING HAPPENED TO US. ON THE OTHER HAND, THE 2 PIECES (COD 254600422), BOTH FROM THE SAME BATCH, BROKE WHEN THE DECOUPLING OF THE DEFINITIVE IMPLANTS WAS CARRIED OUT. IN BOTH CASES, THE RUPTURE OCCURRED AFTER COUPLING AND UNCOUPLING APPROXIMATELY 10 TIMES. THE USE OF THE DEVICE WAS BEING CORRECT. THE INSTRUMENTS ASSOCIATED WITH ATTUNE REVISION WERE USED. THE REALITY IS THAT DUE TO THE SIZE OF THE PLASTIC BONES, IT WAS WORKED WITH TIBIAL BASES 4 AND 5. I TRIED THE 6 AND HAD PROBLEMS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564043 ↗
• MalfunctionApr 22, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING WORKSHOPS, THERE WERE DIFFICULTIES IN MATING THE FB TEST TIBIAL BASES WITH THE LL/MR WEDGE TESTS. ACCORDING TO THE REPORT, IN SOME CASES IT WAS IMPOSSIBLE TO GET THE WEDGE TO BE 100% FIXED TO THE TIBIAL TEST, LEAVING IT SLIGHTLY LOOSE WITH A LIGHT BETWEEN BOTH COMPONENTS. IN OTHER CASES, THE WEDGE SCREW WAS FUSED TO THE TIBIAL BASE, MAKING IT IMPOSSIBLE TO DISENGAGE. IT WAS REPORTED THAT IT WAS SUSPECTED THAT SOME OF THE PARTICIPANTS WERE BEING "ROUGH" WITH THE MATERIALS. HOWEVER, AFTER TESTING, AND EVEN THOUGH THE USER WAS CAREFUL, THE SAME THING HAPPENED. ADDITIONALLY, IT WAS REPORTED THAT THE ATTUNE KNEE SYSTEM REVISION ASSEMBLY OFFSET STABILIZER X2, BROKE WHEN THE DECOUPLING OF THE DEFINITIVE IMPLANTS WAS CARRIED OUT. IN BOTH CASES, THE DEVICE BROKE AFTER COUPLING AND UNCOUPLING APPROXIMATELY 10 TIMES. IT WAS FURTHER NOTED THAT THE USE OF THE DEVICE WAS CORRECT. IT WAS REPORTED THAT DUE TO THE SIZE OF THE PLASTIC BONES, THE DEVICE WORKED WITH TIBIAL BASES 4 AND 5. THE USER HAD PROBLEMS WITH USING THE 6. HOWEVER, IF NECESSARY, IT COULD BE USED. WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957099 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING A WORKSHOP IT WAS NOT POSSIBLE TO PROPERLY FIX THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. IT SEEMS THAT SOMETHING IS WRONG WITH THE TREADS OF THE TRIAL. THEY ARE SOMEHOW COLD WELDED. THE INSTRUMENTS WERE DIFFICULT TO SCREW TOGETHER AND STOPPED WORKING BEFORE THEY ARE FIRMLY CONNECTED. AT THIS POINT, THE ITEMS COULD NO LONGER BE UNSCREWED. (B)(6) IS RELATED TO (B)(6) 10 IPS, (B)(6) 5 IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861054 ↗
• MalfunctionJun 28, 2024Corroded; Corroded

  THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637294 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE DESCRIPTION OF THE CYCLES FOR THE WASHING AND DISINFECTING MACHINES FOR SURGICAL INSTRUMENTS OF THE CONCERNED HOSPITAL'S STERILIZATION CENTER. 01 PRE-WASH (COLD) FOR 120S. 02 EQUIPMENT'S DRAINAGE. 03 WASH 55ºC FOR 600S. 04 EQUIPMENT'S DRAINAGE. 05 RINSING FOR 120S (0ºC). 06 EQUIPMENT'S DRAINAGE. 07 THERMAL DISINFECTION AT 90ºC FOR 300S. 08 EQUIPMENT'S DRAINAGE. 09 DRYING FOR 10S AT 120ºC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994182 ↗
• MalfunctionOct 26, 2023Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STARTED TO RUST DUE TO INCORRECT DETERGENT USED AT THE HOSPITAL. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012107 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001302 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799903 ↗
• MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILE SERVICES IDENTIFIED MULTIPLE INSTRUMENTS WITH RED RESIDUE PRESENT, MAINLY AFFECTING TIBIAL TRIALS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443940 ↗
• MalfunctionAug 20, 2019Corroded; Corroded

  WE SENT OUR NEW ATTUNE REVISION SETS AT THE FIRST TIME TO THE CUSTOMER AND GET THEM BACK WITH SOME RUSTED AREAS. WE DON´T EXACTLY KNOW WHEN THE INCIDENT OCCURED. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910353 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861198 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861194 ↗