ATTUNE 1516-40-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295050490), received between Jan 30, 2018 and Nov 20, 2025 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LACK OF RANGE OF MOTION. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23609307 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE PATIENT WAS HAVING PAIN. THE TIBIA WAS REVISED BUT THE FEMUR WAS KEPT. THERE WAS NO SURGICAL DELAY. WE ARE UNSURE OF THE ORIGINAL IMPLANT DATE.

  Patient problems: Pain

  MAUDE report 20567169 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2023, DUE TO REDNESS, SWELLING AND A POSSIBLE INFECTION AT THE INCISION SITE. NO SURGICAL DELAY REPORTED. DATE OF ORIGINAL IMPLANT WAS (B)(6)2023. THIS REPORT IS FOR AN ATTUNE PS FB INSRT SZ 9 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 17290810 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I & D WASH OUT OF LEFT TOTAL KNEE POLY SWAP OF TIBIAL IMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 17216128 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16385703 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH LIMITED ROM DUE TO PAIN IN THE PATELLA. SURGEON DOWNSIZED THE POLY AND DEBRIDED AROUND THE PATELLA. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15968859 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15707897 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER EXCHANGE DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 12892390 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FLEXION /EXTENSION MISMATCH AND INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12088684 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, DIFFICULTY WALKING, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED A LARGE AMOUNT OF SCAR TISSUE, SOME OF WHICH WAS GRAY. THE PATELLAR AND FEMORAL COMPONENTS WERE WELL-FIXED AND RETAINED. THE TIBIAL TRAY AND TIBIAL INSERT WERE REVISED WITH DEPUY PRODUCTS AND DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 11604104 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020 (UNKNOWN SIDE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9632179 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL BASE AT UNKNOWN INTERFACE. THE CEMENT IS DEPUY CEMENT.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9505674 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS FROM COMPETITOR. THE TIBIAL COMPONENT, FEMORAL COMPONENT AND THE PATELLA WERE REMOVED. THERE WAS NO BONE CEMENT PRESENT TO THE TIBIAL INTERFACE UNDERSIDE. THERE WAS ALSO SLIM TO NO BONE CEMENT IN THE KEELED PORTION OF THE TRAY. LEGAL CLAIM: IT WAS ALSO ALLEGED MEDICAL DEVICE REMOVAL, PAIN, DISCOMFORT, JOINT INSTABILITY AND WALKING DIFFICULTY. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Disorder; No Code Available; Pain

  MAUDE report 9458539 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 01 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION OF POLYETHYLENE EXCHANGE, DUE TO RECURRENT EFFUSION. THE SURGEON REPORTED TISSUE FROM SYNOVECTOMY WAS SENT FOR EVALUATION, WHICH WERE NEGATIVE FOR INFECTION, INFLAMMATION, OR NEUTROPHILS. HE INDICATED THE POLYETHYLENE LINER WAS REMOVED AND THE BOX AND POSTERIOR CAPSULE WERE DEBRIDED. THE PATIENT WAS IMPLANTED WITH THE ATTUNE POLY INSERT, AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014; DOR: (B)(6) 2015 (LT KNEE).

  Patient problems: Edema; No Code Available

  MAUDE report 9224073 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY, A DEEP "CLUNKING" SENSATION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED SIGNIFICANT VASTUS MEDIALIS OBLIQUE ATROPHY. THE FEMORAL AND PATELLA COMPONENTS WERE BOTH WELL-FIX, THE FEMORAL WAS REVISED WHILE THE SURGEON DECIDED TO NOT REVISE THE PATELLA. THE SURGEON NOTED THE TIBIAL TRAY APPEARED TO BE WELL-FIXED, HOWEVER, AFTER EASY REMOVAL THERE WAS NO CEMENT ATTACHED TO THE BACKSIDE OF THE TIBIAL COMPONENT. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8866274 ↗
• InjuryAug 2, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2016; DOR: SEP 18, 2018; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8854849 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGERY WAS BROUGHT BACK FOR AN IRRIGATION AND DEBRIDEMENT AND POLY INSERT EXCHANGE. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8525546 ↗
• MalfunctionNov 14, 2018Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  ATUNNE FEMORAL COMPONENT 9 AND TIBIA COMPONENT 7 WERE USED, WHEN THEY TRIED TO IMPLANT THE ATTUNE INSERT SIZE 9/6MM THE INSERT DID NOT SIT ON THE TIBIAL PLATO, AND APPEARED TO HAVE AN OVERHANG AND THE KNEE COULD NOT FUNCTION PROPERLY. THEY THEN USED THE ATTUNE INSERT 9/5MM WHICH FIT PERFECTLY WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8070756 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I&D INSERT EXCHANGE WAS PERFORMED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002484 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED MEDICAL RECORDS 06/11/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2014. ON (B)(6) 2014, PATIENT HAD A WASHOUT AND WOUND REVISION FOR A SMALL, DIME-SIZED AREA OF SUPERFICIAL WOUND DEHISCENCE. NO IMPLANTS WERE REVISED DURING THAT SURGERY. KNEE WAS THEN REVISED ON (B)(6) 2016 FOR PAIN, SWELLING, AND ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL COMPONENTS. REVISING SURGEON STATED THAT THE CEMENT TO BONE INTERFACE OF THE FEMUR COMPONENT WAS WEAK, WITH SCAR TISSUE PRESENT BETWEEN THE CEMENT AND BONE. THE TIBIAL COMPONENT WAS REPORTED LOOSE, BUT NO CONCLUSIVE INFORMATION WAS PROVIDED REGARDING THE LOOSENING INTERFACE. THE PATELLA COMPONENT WAS REPORTEDLY WELL-FIXED, AND NOT REVISED. DEPUY CEMENT WAS USED DURING PRIMARY. REVISING SURGEON ALSO IDENTIFIED SYNOVITIS AND OSTEOLYSIS, BUT DIDN'T SEE ANY OBVIOUS DAMAGE TO THE INSERT OR PATELLA COMPONENTS. KNEE WAS REVISED TO A COMPETITOR KNEE SYSTEM, WITH THE EXCEPTION OF THE RETAINED DEPUY PATELLA COMPONENT. DOI: (B)(6) 2014; DOR: (B)(6) 2016; (RIGHT KNEE).

  Patient problems: Not Applicable; Osteolysis; Pain; Scar Tissue; Swelling

  MAUDE report 7767498 ↗
• InjuryJan 30, 2018Naturally Worn; Naturally Worn

  LEGAL MEDICAL RECORDS RECEIVED JAN 8, 2018. RIGHT TOTAL KNEE REPLACEMENT FROM (B)(6) 2014 (A REVISION OF A COMPETITOR UNICOMPARTMENTAL ARTHROPLASTY) WAS IN TURN REVISED (B)(6) 2017 FOR PAIN, RECURRENT EFFUSIONS, AND POOR RANGE OF MOTION OF 10-80 DEGREES. REVISING SURGEON IDENTIFIED THAT THE TIBIAL BASEPLATE COMPONENT WAS INTERNALLY MALROTATED APPROXIMATELY 10-15 DEGREES. THERE WAS ALSO NOTED PREMATURE POLYETHYLENE WEAR OF THE FAR POSTERIOR MEDIAL ASPECT OF THE TIBIAL INSERT. SURGEON ALSO INDICATED THAT THE PATELLA COMPONENT WAS UNDERSIZED, WITH ABOUT 12 MM OF LATERAL NATIVE PATELLA BONE UNCOVERED AND MAKING CONTACT WITH THE FEMUR COMPONENT. FEMUR, TIBIAL BASEPLATE AND PATELLA IMPLANT COMPONENTS WERE ALL WELL-FIXED. ALL PRODUCTS WERE REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Swelling

  MAUDE report 7227494 ↗

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