ATTUNE 1516-20-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295045694), received between May 16, 2018 and Jan 15, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO OTHER INFORMATION IS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24081132 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH LAXITY IN THE KNEE AFTER A PREVIOUS SURGERY AT A DIFFERENT HOSPITAL UNDER A DIFFERENT SURGEON. IT WAS DECIDED TO REVISE TO A LARGER POLY INSERT. SURGEON REPLACED 12MM POLY WITH 16MM POLY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15760160 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL PLAYING PICKLE BALL AND COMPLAINED OF PAIN IN HER KNEE. PATIENT KNEE WAS UNSTABLE AND FEMUR BECAME LOOSE AT THE BONE TO CEMENT INTERFACE. IT WAS REVISED TO A TC3. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. DOI:(B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 15439406 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RUPTURED THE PATELLA TENDON AND DOCTOR WANTED TO EXCHANGE INSERT DURING REPAIR. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 13978350 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY SWAP WAS DONE AND SWITCHED TO A LARGER THICKNESS. DOI: (B)(6) 2020. DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11594744 ↗
• InjuryJun 29, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY FIXED-BACK ATTUNE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. UPON ENTERING THE JOINT, THE SURGEON DETERMINED THAT THE PATIENT HAD EXTENSIVE TRICOMPARTMENTAL ARTICULAR CARTILAGE LOSS, POOR SOFT TISSUE, AND FAIR BONE STOCK. THE SURGEON NOTES THAT SOFT TISSUE BALANCING WAS DIFFICULT DUE TO THE PATIENT¿S VALGUS AND TIGHT LATERAL STRUCTURES AND LAXITY EVERYWHERE ELSE. THE TIBIAL AND FEMORAL COMPONENTS WERE IMPLANTED IN SLIGHT EXTERNAL ROTATION TO IMPROVE PATELLAR TRACKING. EXTENSIVE RELEASE OF THE POPLITEUS AND COLLATERAL AND IT BAND PERFORMED TO CORRECT THE VALGUS DEFORMITY AND BALANCE GAPS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT REPORTED TO THE ER 4 DAYS POSTOPERATIVELY WITH PAIN AND INABILITY TO BEAR WEIGHT DUE TO DISLOCATION OF THE LEFT KNEE. THE KNEE WAS REDUCED AND PLACED IN A BRACE. THE PATIENT EXPERIENCED A SECOND DISLOCATION A FEW DAYS LATER AND THE SURGEON DETERMINED THERE WAS TOO MUCH JOINT LAXITY AND RECOMMENDED REVISION OF THE LEFT KNEE. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, WALKING DIFFICULTY, AND RECURRENT DISLOCATIONS SECONDARY TO JOINT LAXITY. UPON ENTERING THE

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

  MAUDE report 10207222 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, LIMB ASYMMETRY, SCAR TISSUE, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016 TIBIAL TRAY, FEMORAL COMPONENT, PATELLA COMPONENT, AND DEPUY CEMENT; DOI: (B)(6) 2017 TIBIAL INSERT; DOR: (B)(6) 2017 RIGHT KNEE.

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

  MAUDE report 9257517 ↗
• InjuryOct 31, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PCL AVULSION.

  Patient problems: Bone Fracture(s)

  MAUDE report 8023525 ↗
• InjuryMay 16, 2018Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS INSERT DISSOCIATION AND MIGRATION INTO THE SUPRAPATELLAR SPACE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT SIDE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Not Applicable

  MAUDE report 7517814 ↗