ATTUNE 1516-30-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295048008), received between Nov 20, 2019 and Aug 28, 2025 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED TO HAVE TIGHTNESS IN THEIR KNEE, SO THE SURGEON REMOVED PREVIOUSLY IMPLANTED POLYETHYLENE INSERT AND DOWNSIZED BY 1MM. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Muscular Rigidity

  MAUDE report 22914317 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION OF LEFT TOTAL KNEE. REMOVED POLY AND PERFORM WASHOUT AND I&D WITH POLY EXCHANGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21631426 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATES PATIENT COMPLAINS BILATERAL TOTAL KNEE IMPLANTS LOOSENED OVER TIME DUE TO TISSUES STRETCHING AND REPLACED 7MM RP POLY WITH A 10MM POLY. DOI: UNKNOWN DATE. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21585851 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATES PATIENT COMPLAINS BILATERAL TOTAL KNEE IMPLANTS LOOSENED OVER TIME DUE TO TISSUES STRETCHING AND REPLACED 7MM RP POLY WITH A 10MM POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21582547 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S NATURAL PATELLA WAS RESURFACED DURING THIS REVISION FOR INSTABILITY. PATELLA RESURFACING AND POLY EXCHANGE WAS PERFORMED. ONLY THE INSERT WAS REVISED. THERE WERE NO LOOSE COMPONENTS. THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT AND NO SURGICAL DELAY. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20708385 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION. SURGEON REMOVED OLD POLY AND PUT IN A NEW AFTER WASH OUT OF THE KNEE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18388298 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RETURN TO THEATRE POST ATTUNE REVISION OF TIBIA DUE TO INSTABILITY POLY REMOVED 7MM INCREASED TO 12MM TO STABILIZE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, FACILITY NAME OF ORIGINAL IMPLANT --> [HOSPITAL], WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> INSTABILITY, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. --> [DATE] REASON FOR REVISION SURGERY. --> INSTABILITY, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> INSTABILITY RETURN TO THEATRE, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, IP-01898998 DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION

  Patient problems: Joint Laxity

  MAUDE report 18325677 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNSTABLE WITH A 7MM POLY. PATIENT REVISED WITH 12MM POLY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18246961 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL COMPONENT AND POLY WERE REMOVED AND REPLACED DUE TO FLEXION INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18230719 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION I&D WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16321432 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12318482 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID AN I & D POLY SWAP. ORIGINAL SURGERY WAS DONE LAST (B)(6) 2020. THE PATIENT HAD PREVIOUSLY DISLOCATED HER KNEE AND NOW PRESENTS WITH A POSSIBLE INFECTION. SURGEON WASHED OUT THE KNEE AND EXCHANGED POLY. WENT TO THICKER POLY. NO INSTRUMENTS WERE BROKEN IN SURGERY, THEREFORE NOTHING REMOVED FROM THE PATIENT. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11282294 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND COMPETITOR BONE CEMENT. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO ARTHROFIBROSIS, AND DECREASED RANGE OF MOTION. THE SURGEON INDICATED EXTENSIVE AMOUNT OF SCAR TISSUE WAS PRESENT ON THE UNDERSURFACE OF THE QUADRICEPS AND ALSO UNDERSURFACE OF THE PATELLAR TENDON. SCAR TISSUE WAS EXCISED. THE PATELLA WAS NOT REVISED. THERE WERE NO COMPLAINTS AGAINST THE FEMORAL NOR TIBIAL COMPONENTS AND THEY WERE REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY COMPONENTS AND COMPETITOR CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2019. (LT KNEE).

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

  MAUDE report 9349628 ↗