ATTUNE 1516-40-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295050483), received between Nov 21, 2017 and May 12, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  IT WAS REPORTED DURING A L2-S1 FUSION PROCEDURE THE DOCTOR MISIDENTIFIED THE LEVELS ON THE PLANNING SCREEN AND THEY INSTRUMENTED L1-L5 INSTEAD OF L2-S1. THEY DID A CONFIRMATION SPIN AND FOUND THE ERROR SO THEY REMOVED THE SCREWS FROM L1 TO PLACE SCREWS AT S1. THEY ALSO FOUND DURING THE SPIN THAT THE L2 RIGHT SCREW'S DISTAL TIP WAS LATERAL TO THE VERTEBRAL BODY BUT OK ON PEDICLE SIDE. THEY REVISED THE L2 RIGHT SCREW AND THEN PLACED THE S1 SCREW. THE REP STATED THAT NEITHER HE NOR THE LOCAL REP SAW ANYTHING THAT LOOKED INCORRECT WHEN THEY WERE IN THE PLANNING SCREEN THAT WOULD HAVE INDICATED THE PLAN WAS ON THE INCORRECT LEVELS. NEXT DAY OF SURGERY: ON (B)(6) 2026. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153630 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WITH STAFF INFECTION, POLY SWAP PERFORMED. DOI- (B)(6) 2019. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25059222 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24936080 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN AND ARTHROFIBROSIS. NO LOOSENING OF IMPLANTS AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24508237 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSSIBLE INFECTED JOINT: WASHED OUT THE KNEE AND EXCHANGED THE POLY ONLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23414372 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSSIBLE INFECTION. KNEE WAS WASHED OUT AND THE LINER WAS EXCHANGED. NO DELAY IN SURGERY OR PATIENT INJURY. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22613160 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STAGE 1 REVISION BEING PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED SUCCESSFULLY. NO DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(4) 2020 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19268424 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY EXCHANGE FOR POSSIBLE INFECTION. NO DELAY. UNABLE TO DETERMINE IF INFECTION IS PRESENT. DOI- (B)(6) 2021. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19165386 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT KNEE REVISION AND PLACEMENT OF SPACER DUE TO INFECTION. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17748437 ↗
• MalfunctionNov 28, 2022Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY LOCKING POLY. AFTER MULTIPLE ATTEMPTS IT WAS FOUND TO HAVE A BENT LOCKING TAB. IT WAS RECOMMEND DEAD BY THE REP AND DECIDED BY THE SURGEON NOT TO PROCEED WITH THIS POLY. 10 -15 MIN SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15868712 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS LOOSENING OF AN UNKNOWN COMPONENT AT AN UNKNOWN INTERFACE. DATE OF IMPLANTATION: (B)(6) 2014, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF ALL COMPONENTS.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 13496920 ↗
• InjuryAug 13, 2021Naturally Worn; Naturally Worn

  ON (B)(6) 2015: PATIENT UNDERWENT A RIGHT TKA DUE TO DJD. PATELLA WAS RESURFACED AND DEPUY CEMENT WAS USED. NO COMPLICATIONS NOTED. ON (B)(6) 2019: PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO ASEPTIC LOOSENING AND INSTABILITY. INTRAOPERATIVE FINDINGS INCLUDED - SWELLING/EFFUSION, MEDIAL LAXITY, FIBROUS SCARRING AND ADHESIONS, AND BLOOD TINGED SYNOVIAL FLUID (SYNOVITIS) THAT WAS ENCROACHING ON THE JOINT CAUSING IMPINGEMENT. THERE WAS A FRAGMENTATION OF THE CEMENT ALONG PERIPHERAL MARGINS OF THE FEMORAL COMPONENT. FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT SLIGHTLY OVERSIZED. THE TIBIAL INSERT SHOWED WEARING AND PITTING ON MEDIAL SIDE. THE PATELLA HAD SOME FLAT SPOT WITH OSTEOLYTIC CHANGES. THE TIBIAL COMPONENT WAS GROSSLY LOOSE WITH SEPARATION OF THE COMPONENT FROM THE CEMENT. MEDIAL TIBIAL BONE LOSS. ALL DEPUY IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR IMPLANTS. ON (B)(6) 2020: PATIENT UNDERWENT AN INSERT EXCHANGED DUE TO INFECTION - COMPETITOR PRODUCTS INVOLVED. DOI: (B)(6) 2015. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Osteolysis; Swelling/ Edema; Synovitis

  MAUDE report 12319470 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY RESECTED THE INFECTED KNEE. DOI: (B)(6) 2016. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11713567 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE ATTUNE ARTHROPLASTY. THE PATELLA WAS RESURFACED, AND CEMENT MANUFACTURER WAS UNKNOWN. THERE WERE NO COMPLICATIONS NOTED. UNKNOWN PART/LOT ON (B)(6) 2019, THE PATIENT PRESENTED WITH STIFFNESS AND RECURRENT HEMATHROSIS. THE PATIENT UNDERWENT A REVISION AND THE TIBIAL COMPONENT WAS FOUND TO BE LOOSE. THE CEMENT WAS DEBONDED FROM THE TIBIAL TRAY. TIBIAL TRAY WAS REMOVED WITHOUT DIFFICULTY AND BONE STOCK WAS IN GOOD CONDITION. THE FEMORAL COMPONENT, AND PATELLA WAS NOTED TO BE WELL FIXED AND IN GOOD CONDITION. NEITHER OF THEM WERE REVISED. AN ATTUNE REVISION TIBIAL TRAY WAS PLACED AS REVISION WITH DEPUY CEMENT USED. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Muscular Rigidity

  MAUDE report 10900395 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED THE ATTUNE INSERT AND REPLACED WITH A THICKER INSERT AND WAS SATISFIED WITH THE STABILITY. DOI: (B)(6) 2014 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10587235 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6) RIGHT AFTER COVID OUTBREAK HAPPENED. DUE TO ALL THE UNKNOWNS, HE WAS UNABLE TO RECEIVE THERAPY POST-OPERATIVELY. HIS KNEE HAD TO BE REVISED DUE TO SIGNIFICANT SCARRING. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10474219 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL SURGERY ON (B)(6), RIGHT AFTER COVID OUTBREAK HAPPENED. DUE TO ALL THE UNKNOWNS, HE WAS UNABLE TO RECEIVE THERAPY POST-OPERATIVELY. HIS KNEE HAD TO BE REVISED DUE TO SIGNIFICANT SCARRING. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10455086 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. FEMUR, INSERT AND TIBIAL WERE ALL REMOVED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10165115 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN. THE SURGEON REPORTED THE PATELLA WAS WELL-FIXED, HAD NO WEAR, AND WAS RETAINED. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH OSTEOTOMES, ALSO WITH NO SIGNIFICANT BONE LOSS. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS REMOVED WITH FLEXIBLE OSTEOTOMES AND NO SIGNIFICANT BONE LOSS. THE PATIENT WAS IMPLANTED WITH COMPETITOR COMPONENTS AND COMPETITOR BONE CEMENT. THERE WERE NOT SURGICAL COMPLICATIONS REPORTED. DOI: (B)(6) 2014; DOR: (B)(6) 2015; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9490485 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO ARTHROFIBROSIS, PAIN, STIFFNESS, AND FLEXION INSTABILITY. THE SURGEON INDICATED THE IMPLANTS WERE ASSESSED AND FOUND TO BE STABLE. HE INDICATED THE TIBIAL COMPONENT WAS REMOVED AND THERE WAS MINIMAL CEMENT LEFT ON THE UNDERSURFACE OF THE TIBIA. BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED. THE SURGEON NOTED THE PATELLA TRACKED WELL. THE PATELLA WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2019; (RT KNEE).

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

  MAUDE report 9317577 ↗
• InjuryAug 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED FOR PAIN AND STIFFNESS. THERE WAS A 5MM POLY IN SO THE OPTION TO DOWNSIZE THE THICKNESS WAS NOT AN OPTION. THE TIBIAL COMPONENT WAS REVISED ONLY. DOI: (B)(6) 2017, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7803165 ↗
• InjuryNov 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7048882 ↗

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