ATTUNE 1516-20-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295046011), received between Sep 13, 2018 and Aug 7, 2025 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FLEXION TIGHTNESS. SURGEON REMOVED THE FEMUR AND DOWNSIZED THE FEMUR. THERE WAS NO DELAY IN THE CASE. AND NO INSTABILITY. THERE WAS NO ISSUE WITH DEPUY IMPLANTS. SURGEON STATED HE OVERSIZED FEMUR. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22741847 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 INCLUDING PATELLA RESURFACING USING COMPETITOR CEMENT. THE PRIMARY OPERATION DID NOT HAVE ANY INTRAOPERATIVE ISSUES. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION FOR SYMPTOMS OF JOINT INSTABILITY, DIFFICULTY WALKING AND PAIN. INTRAOPERATIVELY THE SURGEON STATES BOTH FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE SURGEON DID REQUIRE AN IMPACTOR AND MALLET TO REMOVE BOTH COMPONENTS. THE TIBIAL TRAY HAD ALSO SUBSIDED MEDIALLY. AS THE SURGEON WAS REMOVING THE PATELLAR COMPONENT, HE NOTED THERE WAS HETEROTOPIC BONE LATERALLY THAT WAS REMOVED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 21775902 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. NO LOOSENING IS THERE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20181000 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS THE FIRST STAGE OF A TWO STAGE KNEE REVISION PROCEDURE DUE TO INFECTION. DURING THIS STAGE, THE PATIENT'S PRIMARY KNEE COMPONENTS WERE REMOVED AND REPLACED BY ANTIBIOTIC CEMENT SPACERS. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: ((B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19319733 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TORE HIS QUAD MUSCLE AND SURGEON SWAPPED THE POLY AS A PRECAUTION FOR POSSIBLE INFECTION. NO INFECTION HAS BEEN CONFIRMED. (B)(6). AFFECTED SIDE : LEFT KNEE

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 18383365 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE DECISION WAS MADE TO REMOVE ALL COMPONENTS AND REVISE HIS KNEE IN A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17563403 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS IN OFFICE WITH MILD PAIN AND INSTABILITY. SURGEON BELIEVED PATIENT HAS LIKELY TORN PCL OR IT HAS BECOME NON FUNCTIONAL AS FLEXION LAXITY IS INCREASED RELATIVE TO EXTENSION. INSERT IS REMOVED AND A THICKER INSERT IS REPLACED DRASTICALLY IMPROVING STABILITY. KNEE IS WELL ALIGNED, WELL SIZED WITH AN APPROPRIATE JOINT LINE PROPER POSTERIOR OFFSET. DOI: (B)(6), 2015. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 17540237 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LACKING FULL EXTENSION. POLY SWAP PERFORMED. WENT TO A SMALLER POLY. NOTHING ELSE TO REPORT. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15787904 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15624607 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF REVISION: (B)(6) 2022, DATE OF EVENT: 01 MAR 2022, (LEFT KNEE). TREATMENT: REVISION, INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15494525 ↗
• MalfunctionNov 17, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE TIBIAL INSERT WOULD NOT LOCK INTO TIBIAL TRAY.

  Patient problems: Insufficient Information

  MAUDE report 12828817 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL AT THE CEMENT TO IMPLANT INTERFACE. HE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING PRIOR TO RIGHT KNEE REVISION ON (B)(6) 2018: PAIN, WALKING DIFFICULTY, POPPING SENSATION, INFECTION, AND EFFUSION. ALL COMPONENTS WERE REVISED DURING THE REVISION. IT IS INDICATED THE SAME FEMORAL COMPONENT WAS RE-USED. ALSO, THE PRIMARY STICKER WAS REVIEWED AND SHOWED TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. THE DATE OF PRIMARY DETERMINED TO BE (B)(6) 2015. DOI: (B)(6) 2015 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 11386924 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PRIMARY KNEE REPLACEMENT WITH CR FIXED BEARING ON (B)(6) 2016. PRESENTED TO SURGEON WITH ANTERIOR KNEE PAIN AND DIFFICULTY IN FLEXING KNEE BEYOND 45 DEG. THE PATELLA WAS NOT RESURFACED DURING THE PRIMARY PROCEDURE. THE 6MM FIXED BEARING INSERT WAS REPLACED WITH A 5MM INSERT TO ADDRESS THE FLEXION ISSUE AND THE PATELLA WAS RESURFACED WITH AN ATTUNE ANATOMIC MEDIALIZED IMPLANT.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10860235 ↗
• InjuryOct 19, 2020Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND SWELLING. UPON INSPECTION OF THE INSERT, THE SURGEON SAW THAT IT HAD BECOME DISCOLORED. DOI: UNKNOWN, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10697179 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10661785 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS INSTABILITY, PAIN, AND EDEMA. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: TIBIAL INSERT WAS REVISED.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10301600 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. SURGEON REVISED THE POLY FORM 6MM TO 12MM. DOI: (B)(6) 2014. DOR: (B)(6) 2018. RIGHT KNEE.

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

  MAUDE report 9378480 ↗
• InjurySep 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 PAIN, DISCOMFORT, AND INSTABILITY. THE SURGEON NOTED CLEANING UP SCAR TISSUE ALONG THE ANTERIOR ASPECT OF THE KNEE. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Discomfort; No Code Available; Pain; Scar Tissue

  MAUDE report 8969422 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO UNKNOWN PAIN. A NEW POLY WAS INSERTED. DOI: 2018. DOR: JUN 11, 2019. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8751617 ↗
• MalfunctionSep 13, 2018Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PACKAGING THAT WAS SUPPOSED TO BE STERILE. (WHITE SEALED LAYER) NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872240 ↗