ATTUNE 1516-20-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295046042), received between Nov 26, 2019 and Mar 30, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PRIMARY KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF A PLANNED TWO STAGE REVISION PROCEDURE, ALL OF THE ATTUNE PRIMARY COMPONENTS WERE REMOVED. THE PATIENT'S KNEE WAS THEN THOROUGHLY IRRIGATED AND DEBRIDED. TEMPORARY SURESPACE ANTIBIOTIC SPACERS WERE THEN IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16642684 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REMOVED.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15494541 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; INSERT REMOVED.

  Patient problems: Fall; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 15174056 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS PRODUCT WAS IMPLANTED USING THE FEMUR FIRST TECHNIQUE AND THERE WAS NO CONFIRMATION OF IT BEING INFECTED.

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

  MAUDE report 12128925 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REASON FOR REVISION WAS INFECTION NOT DUE TO LOOSENING OF COMPONENTS.

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

  MAUDE report 11678332 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EDEMA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE).

  Patient problems: No Code Available; Pericardial Effusion; Pulmonary Edema

  MAUDE report 9911283 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (R) KNEE REVISION: PRIMARY IMPLANT DATE: (B)(6) 2018. REASON FOR REVISION: PATIENT WAS IN FIXED FLEXION.

  Patient problems: Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9811528 ↗
• InjuryJan 17, 2020Naturally Worn; Naturally Worn

  ON (B)(6) 2016: THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY. DEPUY IMPLANTS WERE USED. DEPUY CEMENT X2 WAS USED. THE PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS NOTED. ON (B)(6) 2018: THE PATIENT UNDERWENT A LEFT KNEE REVISION SECONDARY TO PAIN AND SWELLING. INTRAOPERATIVELY, THE SURGEON DISCOVERED THAT THE TIBIAL COMPONENT WAS INTERNALLY ROTATED APPROXIMATELY 15-20 DEGREES; EFFUSION; WEAR ON THE BACK SIDE OF THE TIBIAL INSERT; AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2016; DOR: (B)(6) 2018 LT KNEE.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9602223 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE INSTABILITY. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9540228 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A FIRST RIGHT KNEE REVISION. IN ADDITION TO THE PREVIOUSLY INDICATED ISSUES, THE PATIENT WAS ALSO EXPERIENCING PCL DEFICIENCY. TIBIAL INSERT EXCHANGED COMPLETED. TASK CREATED TO UPDATE PC. ON (B)(6) 2020, THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION TO ADDRESS PAIN, SCAR REMOVAL, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. TASK INITIATED TO CREATE NEW PC TO CAPTURE SECOND REVISION.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9497124 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY SURGERY ON THE LEFT KNEE DUE TO OSTEOARTHRITIS. THE SURGEON NOTED THERE WERE NO COMPLICATIONS. THERE IS NO EVIDENCE OF REVISION. DOI: (B)(6) 2014 . DOR: NONE. LEFT KNEE.

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

  MAUDE report 9375705 ↗