ATTUNE 1516-50-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295052470), received between Dec 14, 2017 and Jul 27, 2026 — classified as 30 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had painful knee.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Pain

  MAUDE report 50041363 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25576796 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE WASHOUT OUT WITH LINER EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21653579 ↗
• InjurySep 5, 2024Adverse 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 POSSIBLE INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20147363 ↗
• InjuryAug 27, 2024Adverse 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 KNEE INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20078501 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18580039 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MID FLEXION INSTABILITY. POLY WAS REVISED AND UPSIZED ON DEC 8, 2022. THE PATIENT STILL FELT UNSTABLE IN FLEXION AFTER UPSIZING. REASON FOR THE SURGERY WAS TO REMOVE COMPONENTS AND ADDRESS THE FLEXION OR EXTENSION MISMATCH. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 18247890 ↗
• MalfunctionJun 5, 2023Expiration Date Error; Expiration Date Error

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE FOLLOWING: THERE WAS A DELAY DURING THE SURGERY OF ABOUT 10 MINUTES. THE TIME TO CHECK IN THE EXTERNAL DEPOT FOR THE PRESENCE OF ANOTHER VALID IMPLANT IN STOCK. NO CONSEQUENCES FOR THE PATIENT FOR THE MOMENT. PTG REVISION WAS TO REMOVE AN ATTUNE DPS CEMENTLESS TIBIA THAT HAD SUNK INTO THE ANTERIOR TIBIA. WE HAD TO GET LEVEL ON THE TIBIAL PLANE, SO CUT AGAIN, WHICH CHANGED OUR LINE SPACING AND LED TO THE NEED FOR A THICKER INSERT. THAT IS THE 5/12 INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063228 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RIGHT KNEE WAS REVISED DUE TO INFECTION. A MOBILE SPACER WAS PLACED AND ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16761461 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF TOTAL KNEE ARTHROPLASTY. IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH A POLY EXCHANGE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16761040 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE POLY. POLY SWAP PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16003956 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ¿VOLUNTARY REPORT RECEIVED (MW5111773) DEPUY ATTUNE TIBIA PLATE FAILURE. FDA SAFETY REPORT ID# (B)(4)." DOI: UNKNOWN; DOR: UNKNOWN; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15527437 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST STAGE RE REVISION DONE DUE TO INFECTION. ORIGINAL FIRST STAGE REVISION DONE ON THE (B)(6) 2022 AT FLINDERS PRIVATE BY THE SURGEON. DOI: (B)(6) 2022. DOR:(B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14914966 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED THE MCL. THE SURGEON REMOVED THE PRIMARY KNEE COMPONENTS AND IMPLANTED CRS ATTUNE REVISION SYSTEM. UNKNOWN BONE CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 14827860 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL IN SHOWER, AND HAVING PAIN AND WAS TENDER TO TOUCH AND HAVING HARD TIME EXTENDING KNEE. KNEE ASPIRATED RESULTS OF HIGH WBC¿S, RBC¿S WITH 94%NEUTROPHILS, CULTURE CAME BACK AS STAPH CAPRAE. PATIENT HAVING KNEE EXPLANTED AND ANTIBIOTIC SPACER IMPLANTED. DOI : (B)(6) 2020 ; DOR : (B)(6) 2021 ; RIGHT SIDE.

  Patient problems: Fall; Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 13203467 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL KNEES (B)(6) 2020. OVER THE TIME, THE PATIENT'S TISSUES HAVE "LOOSENED" AND THICKER SPACERS ARE REQUIRED. NO PRESENCE OF INFECTION. BOTH INSERTS WERE REPLACED FOR THICKER SIZES. DOI: (B)(6) 2020 DOR: (B)(6) 2021 UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12934799 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12638355 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON CONDUCTS IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE PROCEDURE. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11851834 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D AND POLY EXCHANGE WAS DONE. DOI: (B)(6) 2021. DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11851750 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS PAIN, TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, AND OSTEOLYSIS AROUND THE TIBIA. THE TIBIAL TRAY AND TIBIAL INSERT WERE REVISED. THE PATELLAR AND FEMORAL COMPONENTS WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Osteolysis; Pain

  MAUDE report 11737491 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS FOR OSTEOARTHRITIS. DEPUY IMPLANTS PLACED WITH DEPUY CEMENT X2 (BOTH KNEES). NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2017: PATIENT UNDERWENT A RIGHT KNEE REVISION FOR PAIN AND MID FLEXION INSTABILITY. A RARE GRAM+ COCCI WAS FOUND ON CULTURES, BUT WAS THOUGHT TO BE A CONTAMINATE GIVEN THE CLINICAL PICTURE. THE TIBIAL TRAY WAS FOUND TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY AND INSERT WERE REVISED. THE FEMORAL COMPONENT AND PATELLA WERE LEFT IMPLANTED WITH NO ALLEGATIONS. DEPUY TIBIAL TRAY, TIBIAL STEM, AND INSERT WERE PLACED. COMPETITOR CEMENT WAS USED AT REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 11581021 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND WAS SCHEDULED FOR AN I&D, THE SURGEON CHOSE TO DO CHANGE THE POLY INSERT. NO EVIDENCE OF GROSS INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Fall; Swelling/ Edema; Wound Dehiscence

  MAUDE report 10895280 ↗
• InjuryOct 28, 2020Unintended Movement; Unintended Movement

  PATIENT WAS REVISED TO TREAT JOINT INSTABILITY SECONDARY TO INSERT SPIN OUT AND DISLOCATION. EXTRACTED THE ATTUNE FEMUR, ATTUNE RP TRAY, AND ATTUNE RP 12MM INSERT. MEDIALIZED DOME PATELLA WAS IN GREAT SHAPE, THAT WAS NOT EXPLANTED. THE SURGEON WENT TO A MORE CONSTRAINT SYSTEM, ATTUNE CRS IMPLANTS. IMPLANTED A SZ 6 CRS FEMUR, REV FIXED BEARING TRAY WITH OFFSET PRESSFIT STEM AND AN 18MM CRS FIXED BEARING INSERT. DOI: (B)(6) 2020, DOR: (B)(6) 2020 (INSERT REVISED , PREVIOUSLY REPORTED), DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10752775 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WERE QUESTIONS OF LOOSENING ON THE TIBIAL COMPONENT PRIOR TO SURGERY. IT WAS DETERMINED INTRA-OPERATIVELY THAT THE TIBIAL AND FEMORAL COMPONENTS WERE NOT LOOSE. POLY WAS EXCHANGED AND AN AGGRESSIVE SYNOVECTOMY WAS PERFORMED. DOI: (B)(6) 2018. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9586534 ↗
• InjuryJan 10, 2020Adverse 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 A PAINFUL RIGHT KNEE. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9577986 ↗