ATTUNE 1516-20-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295045687), received between Sep 11, 2017 and Jan 8, 2024 — classified as 12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF TIBIAL. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: (B)(6) 2023 DATE OF REVISION:(B)(6) 2023, (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Osteolysis; Synovitis

  MAUDE report 18464578 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD POLY LINER REVISED FOR DUE TO INSTABILITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17774328 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A WASHOUT WAS PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15340896 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINS OF KNEE BEING UNSTABLE. SURGEON AGREED THAT WITH HER LOSING 100LBS SHE FELT SLIGHTLY UNSTABLE. HE PROCEEDED WITH SURGERY AND FOUND ALL COMPONENTS WELL FIXED AND CHANGED HER POLY TO A LARGER THICKNESS. SUCCESSFUL SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12160914 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY, WITH ANKYLOSIS AND ARTHROFIBROSIS PATIENT RECEIVED A LEFT KNEE REVISION AND LYSIS OF ADHESIONS TO TREAT PAIN, INSTABILITY, DECREASE IN JOINT FLEXION TO 95 DEGREES, ANKYLOSIS, AND ADHESIONS. UPON ENTERING THE JOINT, PERIARTICULAR EFFUSION WAS EVACUATED. EXTENSIVE DISTAL FEMORAL AND PATELLAR TENDON ADHESIONS WERE EXCISED WHICH INCREASED JOINT FLEXION TO 130 DEGREES. THE INSERT WAS REVISED TO TREAT THE MEDIAL LATERAL AND ANTERIOR JOINT LAXITY. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A DEPUY INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 11272591 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO HEMATOMA AND FALL. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9525725 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF INSTABILITY IN BOTH FLEXION AND IN EXTENSION AFTER SEVERAL YEARS SINCE HER ORIGINAL SURGERY. PLAN WAS TO PUT IN A THICKER POLY, IF UNSUCCESSFUL A FULL REVISION WAS GOING TO BE PERFORMED. AFTER TRIALING SOME THICKER POLYS, A SIZE 16MM WAS FOUND TO BE SATISFACTORY WITH A FULL RANGE OF FLEXION THROUGH EXTENSION. ONLY THE POLY WAS REMOVED. ALL OTHER IMPLANTS REMAINED. DOI: (B)(6) 2015; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9505553 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, ADHESIONS, DIFFICULTY WALKING, AND A MIGRATED AND LOOSE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015; DOR: (B)(6) 2016; LEFT KNEE.

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

  MAUDE report 9321775 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A TIBIAL INSERT EXCHANGE OF THE RIGHT KNEE DUE TO PAIN, DISCOMFORT, AND INSTABILITY. DOI: (B)(6) 2016 DOR: (B)(6) 2017 RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 9249823 ↗
• InjuryOct 17, 2018Unstable; Unstable

  LITIGATION ALLEGES KNEE REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 7975625 ↗
• InjuryMar 22, 2018Naturally Worn; Naturally Worn

  REVISION FOR: PAIN ON TIBIAL SIDE , AFTER 3 MONTHS OK. WHEN TIBIA BASE PLATE INSPECTED INTRA-OPERATIVELY FOUND TO BE LOOSE, WHEN REMOVED FROM PATIENT FOUND NO CEMENT ON IMPLANT. POLY WEAR. DOI: (B)(6) 2016; DOR: (B)(6) 2018; UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 7361664 ↗
• InjurySep 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE DER INDICATES THAT SURGEON STATES THE PATIENT DISLOCATED HER KNEE POSTERIORLY POST-OPERATIVELY WHILE STILL IN THE HOSPITAL. HE DID A REDUCTION UNDER ANESTHESIA AND FELT THE KNEE WAS STABLE. AFTER THE PATIENT LEFT THE HOSPITAL SHE DISLOCATED POSTERIORLY AGAIN WHILE GETTING OFF THE TOILET. SURGEON BROUGHT THE PATIENT TO THE OR FOR A REVISION. IT WAS DETERMINED INTRA-OP THAT THE MEDIAL SIDE OF THE KNEE JOINT OPENED UP 1CM. PRIMARY INSERTS WERE TRIALED AND THE DECISION WAS MADE TO CONVERT TO A TC3 RP KNEE FOR STABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 6855596 ↗