ATTUNE 1520-20-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295542568), received between Apr 12, 2024 and Sep 24, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that I & D poly swap was done for infection.Affected side-Right knee.

  Patient problems: Unspecified Infection

  MAUDE report 50881488 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patella became dysfunctional and the poly was switched while open to resurface patella.DOI: (b)(6) 2024.DOR: (b)(6) 2026.Affected side: Right knee.

  Patient problems: Joint Laxity

  MAUDE report 50059532 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LIMITED RANGE OF MOTION; SURGEON OPTED TO CHANGE POLY AND PATELLA TO INCREASE ROM. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 24214810 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN KNEE. UPSIZE POLY. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24041530 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AT HOME AND THE WOUND DEHISCED DOWN TO JOINT. DOCTOR DID A POLY SWAP. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23303186 ↗
• MalfunctionSep 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON WENT TO IMPACT THE 6X5MM MS POLY AND IT WASN¿T PROPERLY SEATING AND LOCKING INTO THE TRAY. SURGEON REMOVED THE 5MM INSERT, TRIED A 6X6MM MS POLY AND IT DID THE SAME THING. NOT PROPERLY SEATING AND LOCKING INTO THE TRAY. SURGEON HAD US OPEN A 6X7MM MS POLY AND THAT ONE SEATED PROPERLY. IT ADDED ABOUT 5 MINS TO TOTAL CASE TIME. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965561 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN OFFICE POST FALL ROUGHLY 6 WEEKS PRIOR POST TOTAL KNEE. SHE NOW COMPLAINS OF PAIN AND INSTABILITY. PHYSICAL EXAM LED SURGEON TO BELIEVE SHE HAD RUPTURED HER MCL AT THE TIME OF FALL AND SHE IS SCHEDULED FOR A REVISION TO ADDRESS. PATIENT HAD BEEN DOING WELL PRIOR TO THE STATED FALL AND WAS VERY HAPPY WITH HER KNEE PRIOR TO THE FALL. PATIENT IS MORBIDLY OBESE AND IS CONSIDERED A CONTRIBUTING FACTOR. DURING SURGERY, THE MCL WAS CONFIRMED TO BE DEFICIENT, ESPECIALLY AT HER SIZE, AND WELL FIXED AND WELL ALIGNED COMPONENTS WERE REMOVED AND A HINGED KNEE CONSTRUCT WAS PLACED WITH NO DELAY NOR PATIENT HARM. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 22565554 ↗
• MalfunctionJun 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHEN THE SURGEON INSERTED THE POLY, IT WAS NOTICED THAT THE LATERAL POSTERIOR EDGE WAS LIFTED. THE POLY WAS REMOVED AND SURGEON TRIED AGAIN WITH THE SAME RESULT. A NEW POLY WAS OPENED AND IT WENT IN PERFECTLY DOE: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331508 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE WAS REVISED FOR SURGEON'S SUSPICION OF INFECTION. POLY SWAP AND I&D WAS PERFORMED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22205938 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED AND THE SURGEON IS SWAPPING OUT POLY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22157885 ↗
• InjuryMar 25, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT WANTED TO COMPLAIN THAT THE IMPLANT WAS NOT WORKING AT ALL.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Fall; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21686477 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION STATES THAT: WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? ONLY THE EXTRA SURGERY.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 21597195 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SWOLLEN PAINFUL POST OP TKA. KNEE WAS ASPIRATED FOR CELL COUNT. SURGEON PERFORMED ARTHROTOMY, REMOVED POLY AND WASHED OUT THE KNEE EXTENSIVELY. NEW POLY THAT WAS THE SAME SIZE AS REMOVED WAS IMPLANTED AND KNEE CLOSED IN NORMAL FASHION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21313229 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP DUE TO UNSTABLE KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20772662 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REFERRED POST TKA FOR INFECTION. SURGEON CHOSES TO PERFORM A ONE STAGE REVISION TKA WITH A DUAL SET UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. ALL WELL FIXED WERE COMPONENTS REMOVED AND A THOROUGH IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED PRIOR TO PREPPING FOR NEW COMPONENTS. A PORTION OF THE THE ANTERIOR TIBIA CAME OFF WHEN THE TIBIA COMPONENT WAS REMOVED HOWEVER THE SLEEVE HAD GOOD FIXATION WHEN PREPARED. NO DELAY WAS EXPERIENCED. THERE WAS NO LOOSENING BUT DEPUY CEMENT HAS BEEN USED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19361827 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL ON POST-OP DAY ONE AND OPENED THE WOUND. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 19098706 ↗