ATTUNE 1516-50-908Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295053019), received between May 9, 2018 and Jan 6, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR SEPTIC WASHOUT W/ INSERT CHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 23977149 ↗
• InjuryAug 20, 2025Adverse 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 ARTHROFIBROSIS. SYNOVECTOMY & POLY EXCHANGE PERFORMED. THERE WAS NO DELAY AND NO ADVERSE EFFECTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 22848910 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED THEIR RIGHT QUADRICEPS. WHILE REPAIRING THE QUAD, SURGEON EXCISED ALL SCAR TISSUE AND PERFORMED A POLY EXCHANGE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Adhesion(s); Fall; Unspecified Tissue Injury

  MAUDE report 22319624 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY. FLEXION/EXTENSION MISMATCH. FEMUR AND POLY WERE EXPLANTED. CRS FEMUR, AUGS, STEM, AND THICKER POLY WERE IMPLANTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18948922 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SWELLING, CAUSE UNKNOWN. POLY SWAP DONE UPON KNEE EXPLORATION. FEMUR AND TIBIA TESTED FOR STABILITY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 18902781 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMUR AND TIBIA WHERE REVISED DUE TO INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16478030 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID THE ORIGINAL SURGERY ON (B)(6) 2016 AT (B)(6). SURGEON REVISED THE TIBIA ON (B)(6) 2018. TODAY SURGEON BROUGHT THE PT BACK TO ADDRESS HIS CONTINUED PAIN AND REVISED THE FEMUR. AFTER TAKING THE FEMORAL COMPONENT OFF IT WAS NOTED THE A SIGNIFICANT PORTION OF THE CEMENT DIDN¿T APPEAR TO ADHERE TO THE PATIENTS BONE POSTERIOR AND DISTAL. IT WAS STILL STUCK TO THE FEMORAL COMPONENT. THE SURGEON THEN PROCEEDED TO REVISE THE FEMUR LEAVING THE TIBIA THAT HE REVISED IN PLACE FROM 9/19/18. ON THE ORIGINAL SURGERY, SURGEON USED STRYKER CEMENT AND NOT DEPUY. THIS PC CAPTURES THE TIBIAL TRAY REVISION ON (B)(6) 2018. DOI: (B)(6) 2016, DOR: (B)(6) 2018, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15518146 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE'S NO SURGICAL DELAY.

  Patient problems: Muscular Rigidity

  MAUDE report 13025435 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNABLE TO FLEX PAST 90 DEG, REQUIRED POLYETHYLENE INSERT TO BE DOWNSIZED VIA REVISION, PATIENT HAD PREVIOUSLY BEEN TREATED FOR OTHER MEDICAL ISSUES WHICH RESULTED IN HIM NOT BEING ABLE TO MOBILIZE AT THE TIME OF PRIMARY OPERATION REPORT OF INFLAMMATION, SCAR TISSUE CAUSING INABILITY TO FULLY EXTEND AND FLEX THE KNEE.

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

  MAUDE report 11475429 ↗
• InjuryOct 9, 2018Naturally Worn; Naturally Worn

  RIGHT REVISION TO ADDRESS PAIN, INSTABILITY, QUAD ATROPHY AND QUAD WEAKNESS, EFFUSION, AND LOOSENING OF THE TIBIAL COMPONENT AT THE IMPLANT/CEMENT INTERFACE. THERE WAS WEAR WITH GROOVING AND PITTING TO THE UNDERSIDE OF THE ROTATING PLATFORM. THERE WERE CRACKS IN THE CEMENT AND A SMALL CRACK IN THE MEDIAL CONDYLAR REGION, NOT COMPLETE, BUT CONSISTENT WITH PROBABLE STRESS FRACTURE. PATELLA WAS NOTED TO BE OVERSTUFFED.

  Patient problems: Edema; No Code Available; Pain; Swelling; Weakness

  MAUDE report 7948938 ↗
• InjuryMay 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS SURGERY SITE INFECTION. THE PATIENT UNDERWENT INCISION AND DRAINAGE WITH POLY EXCHANGE. ALL OTHER PARTS REMAIN IN SITU. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7497951 ↗