ATTUNE 1516-30-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295047759), received between Aug 28, 2017 and Mar 13, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING: LITIGATION RECORD RECEIVED. ON (B)(6) 2024, THE PLAINTIFF UNDERWENT BILATERAL KNEE REPLACEMENT SURGERY. FOLLOWING THE SURGERY, THE PLAINTIFF DEVELOPED SERIOUS COMPLICATIONS, INCLUDING SEVERE AND PERSISTENT PAIN IN BOTH KNEES, INSTABILITY, AND DIFFICULTY WITH MOBILITY. THE PLAINTIFF CONTINUES TO EXPERIENCE CHRONIC PAIN, LIMITED MOBILITY, FEAR OF FALLING, EMOTIONAL DISTRESS, AND LOSS OF INDEPENDENCE.

  Patient problems: Adhesion(s); Distress; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection

  MAUDE report 24588975 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS' SOFT TISSUES BECAUSE LAX. HAD TO REVISE THE FEMUR AND POLY. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23495977 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21860449 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TOTAL KNEE WAS REVISED DUE TO COMPLAINING OF PAIN. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19381166 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS BEING EVALUATED FOR CHRONIC INFLAMMATION. POLYETHYLENE WAS EXCHANGED FOR A THICKER ONE FOR GREATER STABILITY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Inflammation; Joint Laxity

  MAUDE report 17941388 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON TOOK OUT A 6MM POLY AND PUT IN A 10MM POLY FOR UNKNOWN REASON. THERE WAS NO PRODUCT FAILURE. THIS IS ALL THE INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17710686 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR PERFORMED A REVISION TOTAL KNEE ON PATIENT COMPLAINING OF PAIN. (B)(6) 2022, (B)(6) 2023, UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 16822676 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO LOOSENING, ONLY PAIN ON THE DISTAL TIBIAL KEEL. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 16246433 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD ON 5 OCT 2022 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2017, PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS OF THE RIGHT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED IN THE OPERATIVE NOTE. ON (B)(6) 2022, THE PATIENT HAD A REVISION TO ADDRESS FAILED RIGHT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED: INSTABILITY, AND INTRAOPERATIVE FINDING, PAIN, RECURRENT EFFUSIONS, OF LOOSEN TIBIAL TRAY AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT WAS REMOVED. COMPETITOR COMPONENTS WERE USED DURING THIS PROCEDURE, THE DEPUY PATELLA WAS RETAINED. DOI: (B)(6) 2017 DOR: (B)(6) 2022 (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15672612 ↗
• InjuryJun 29, 2022Unintended Movement; Unintended Movement

  PATIENT HAD A KNEE REPLACEMENT IN MAY USING ATTUNE MOBILE BEARING CR. PATIENT HAD BEARING SPIN WHICH WAS REDUCED UNDER ANAESTHETIC. SURGEON WOULD LIKE TO KNOW WHY WE HAVE REMOVED THE X-RAY MARKERS FROM THE POLY WHEN COMPARING TO LCS AS IT¿S DIFFICULT TO DIAGNOSE A BEARING SPIN WITHOUT IT. DOI: (B)(6) 2022, DOR: UNKNOWN, UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14853335 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR ANTERIOR KNEE PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14828525 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA ON (B)(6) 2021. THE PATIENT EXPERIENCED STIFFNESS AND LOST ROM SOME TIME FOLLOWING PROCEDURE. THE SURGEON DISCOVERED PATIENT DEVELOPED ARTHROFIBROSIS AROUND THE KNEE CAUSING STIFF. REVISION COMPLETED IN WHICH THE FEMORAL COMPONENT AND INSERT WERE EXPLANTED AND REPLACED WITH A PS FEMORAL COMPONENT AND PS INSERT. THE TIBIAL BASE PLATE AND PATELLA REMAINED. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 13283216 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT EXCHANGED DUE TO INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 13176946 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 12391523 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH PAIN AND INSTABILITY. SO SURGEON REMOVED ALL COMPONENTS AND REPLACED WITH ATTUNE REVISION TO IMPROVE STABILITY. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12167855 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN. THE FEMORAL COMPONENT WAS FOUND TO BE MALPOSITIONED. COMPETITOR CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11483439 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS DONE. INCREASED POLY FROM 6 TO 8. DOI: UNKNOWN, DOR: (B)(6) 2020, UNK AFFECTED SIDE.

  Patient problems: Joint Laxity

  MAUDE report 10991392 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT¿S RIGHT KNEE JOINT. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INFECTION WHICH OCCURRED AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED THE FEMORAL COMPONENT, THE TIBIAL TRAY AND THE TIBIAL INSERT AND IRRIGATED THE KNEE JOINT. HE SET ANTIBIOTIC CEMENT MOLD AND COMPLETED THE REMOVAL SURGERY WITHOUT ANY SURGICAL DELAY. THE SURGEON PLANS THE REVISION SURGERY AFTER THE INFECTION GOES AWAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10690055 ↗
• InjuryMay 12, 2020Adverse 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 THE CEMENT TO IMPLANT INTERFACE. TIBIAL COMPONENT CAME OUT WITHOUT ANY CEMENT OR BONE ON THE IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10048465 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE IS SHOWING SIGNS OF INFECTION. THE SURGEON WAS PERFORMING POLY SWAP AND DEBRIDEMENT OF KNEE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9953855 ↗
• InjuryApr 9, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAS ROTATED HIS FEMUR OFF THE TIBIAL POLYETHYLENE IMPLANT. HE CORRECTED IT ONCE WITH A POLY REVISION BUT IT HAS SPUN OUT AGAIN A MONTH LATER. DOI: UNKNOWN. DOR: UNKNOWN; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pleural Effusion

  MAUDE report 9943985 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: PATIENT UNDERWENT A LEFT KNEE REPLACEMENT. ATTUNE IMPLANTS WERE PLACED WITH DEPUY CEMENT X2. THE PATELLA WAS RESURFACED. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: PATIENT UNDERWENT A LEFT KNEE REVISION. TIBIAL LOOSENING WAS NOTED WITH VARUS COLLAPSE. NO CEMENT WAS ADHERENT TO THE BACK OF THE TRAY. THERE WAS SIGNIFICANT MEDIAL BONE LOSS AND LYSIS NOTED. LEG LENGTH DISCREPANCY WAS NOTED FROM THE VARUS COLLAPSE. COMPETITOR PRODUCTS WERE PLACED AT REVISION. DOI: (B)(6) 2016; DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9683029 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. NO PREVIOUS REVISION. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9661488 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DUE TO INFECTION. I&D AND POLY EXCHANGE WAS PERFORMED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9362134 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY. THE REVISION OPERATIVE NOTE INDICATED BLOOD LOSS OF 600 ML DURING THE PROCEDURE. THE SURGEON NOTED A COMPLEX DEFORMITY OF THE TIBIA WITH INTERNAL TIBIAL TORSION ABOUT THE PROXIMAL TIBIAL PLATEAU AND S-SHAPED TIBIA. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015. DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Blood Loss; Joint Disorder; No Code Available

  MAUDE report 8969495 ↗