ATTUNE 2546-00-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295438731), received between Feb 19, 2019 and Sep 18, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828964 ↗
• MalfunctionDec 9, 2025Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760961 ↗
• MalfunctionJul 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ITEMS FROM THE ATTUNE REVISION SET WERE REPORTED FOR AN UNKNOWN ALLEGATION.

  Patient problems: Insufficient Information

  MAUDE report 22588048 ↗
• MalfunctionDec 11, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT HANDLE IS STICKING AND NOT SLIDING LIKE IT SHOULD - WE HAVE TRIED TO LUBRICATE HOWEVER UNSUCCESSFUL. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (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 18306324 ↗
• MalfunctionNov 29, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE SYSTEM HANDLE LATCH DID NOT OPEN ALL THE WAY. IT WAS STILL USABLE IN THE CASE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18226940 ↗
• MalfunctionApr 17, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE CONNECTION PART THAT CONNECTS HANDLE TO TIBIAL TRIAL BASE PLATE HAS BECOME DAMAGED, MISSHAPEN SO THAT IT ISN¿T CONNECTING THE 2 PARTS TOGETHER. THE DAMAGE THAT OCCURRED IS THAT IT HAD BECOME DENTED SO WOULD NO LONGER CONNECT OVER THE TIBIAL TRAY FITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751897 ↗
• MalfunctionJan 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIGGER ON THE HANDLE DOESN¿T FIRE PROPERLY. WHEN YOU PULL DOWN ON IT TO TRY TO RELEASE IT, IT IS VERY DIFFICULT AND REQUIRES A LOT OF STRENGTH TO GET IT TO FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11149881 ↗
• MalfunctionOct 1, 2020Break; Break

  INSTRUMENT'S TRIGGER HANDLE WAS FOUND TO BE BROKEN UPON ROUTINE CHECK OF THE INSTRUMENTATION BY THE REGIONAL MANAGER FOR FORM/FIT/FUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613293 ↗
• InjurySep 11, 2020Loose or Intermittent Connection; Device Slipped; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Device Slipped; Appropriate Device Problem Term/Code Not Available

  DURING A 2ND STAGE KNEE REVISION THE SURGEON REPORTED FRACTURING THE PROXIMAL TIBIA WHEN SEATING THE THE ATTUNE REVISION TIBIAL BROACH IN THE PROXIMAL TIBIA. THE SURGEON HAD ALREADY PREPARED THE PROXIMAL TIBIA BONE WITH A STEM PILOT/BROACH AND TIB TRAY HOWEVER WHEN HE EXTRACTED THE TRIAL CONSTRUCT (WITH RP ADAPTER AND SYSTEM HANDLE) THE TIB TRAY ROTATION WAS NOT LOCKED AND THEREFORE HE WAS REQUIRED TO RE-SEAT THE STEM TRIAL/BROACH INTO THE PREPARED BONE ENVELOPE AND LOCK OFF HIS RP TRAY ROTATION BEFORE EXTRACTING AND TRANSFERRING THIS TO THE DEFINITIVE IMPLANT/ASSEMBLING. HE COMMENTED THAT WHEN THE REGISTRAR RE-INSERTED THE BROACH INTO THE BONE SHE HIT IT TOO HARD WHICH HE THINKS CAUSED THE FRACTURE. IT WAS WORTH NOTING THAT THE REGISTRAR ALSO HAD GREAT DIFFICULTY EXTRACTING THE TRIAL STEM AND BROACH/TRAY CONSTRUCT ONCE THE ROTATION HAD BEEN LOCKED AND WHEN THE SURGEON TOOK OVER, HE ENDED UP REMOVING THE RP TRIAL TRAY AND ATTACHING THE BROACH HANDLE TO REMOVE THE BROACH (WHICH IS WHEN HE NOTICED THE SMALL FRACTURE IN THE PROX TIB) AND REPEATING THE ABOVE STEPS TO SET THE ROTATION. THE SURGERY CONTINUED AS PLANNED AND HE ADVISED THAT THIS FRACTURE WOULD NOT CHANGE THE OUTCOME OF THE

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10521855 ↗
• MalfunctionJul 21, 2020Break; Break

  SLAP HAMMER BROKE OFF IN REVISION IMPACTOR. RUBBER WAS BROKEN IN ATTUNE IMPACTOR. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN, DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4): DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (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 Consequences Or Impact To Patient

  MAUDE report 10306245 ↗
• MalfunctionJun 4, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE TRIGGER WAS STIFF AND WONT RELEASE INSTRUMENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10118997 ↗
• MalfunctionMar 12, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LOCKING MECHANISM STICKS, WON'T LOCK. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824073 ↗
• MalfunctionJul 19, 2019Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND CRACKED, NOT LATCHING AND BROKEN IN OFFICE SETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807864 ↗
• MalfunctionMay 22, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENTS AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT HAS OSTEOLYSIS AND METALLOSIS BLACK TISSUE DUE TO METAL AND POLY WEAR IN THE KNEE. THE COMPONENTS WERE REMOVED AND NEW IMPLANTS INSERTED. DURING THE REVISION, THE ATTUNE REVISION HANDLE WOULD NOT LOCK OR RELEASE PROPERLY AND STUCK NUMEROUS TIMES. THE PRESS FIT TIBIAL TRAY WAS LOOSE, AND THE FEMUR AND PATELLA WERE FIXED. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633428 ↗
• MalfunctionFeb 19, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE REVISION 29MM SLEEVE BROACH GOT STUCK IN THE TIBIA. BOTH BROACH HANDLE KEPT RELEASING ON EXTRACTION. THE SMALL END OF THE EXTRACTOR ROD WAS INSERTED INTO THE BROACH AND A CROSSBAR WAS PUT THROUGH THAT TO EXTRACT THE SLEEVE. TRYING TO GET THE ROD OUT OF THE BROACH AND THE TIP BROKE OFF INSIDE. THE 37MM BROACH WAS INSERTED NEXT AND IT GOT STUCK ALSO. BOTH BROACH HANDLES KEPT RELEASING. WITH THE EXTRACTION ROD BROKEN THE SURGEON SCREWED THE TRIAL RP BASE PLATE ONTO THE BROACH. TRIED EXTRACTING THE WHOLE CONSTRUCT WITH THE SYSTEM HANDLE AND THE BOX ADAPTER. THE SYSTEM HANDLE KEPT RELEASING ALSO. IT EVENTUALLY WAS ABLE TO BE WORKED OUT WITH THIS CONSTRUCT.

  Patient problems: Not Applicable

  MAUDE report 8349611 ↗