ATTUNE 1516-30-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295048114), received between Nov 26, 2018 and Oct 9, 2024 — classified as 14 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DID WELL FOR A COUPLE YEARS POST TOTAL KNEE REPLACEMENT AND THEN THEY STARTED LOSING RANGE OF MOTION. 6MM POLY WAS REMOVED AND SCAR TISSUE WAS REMOVED. 5MM POLY WAS PUT IN AND THE KNEE WAS STABLE, AND RANGE OF MOTION WAS RESTORED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 20411543 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SYNOVECTOMY WAS PERFORMED, CHANGING THE POLY WITHOUT ANY DELAYS. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Synovitis

  MAUDE report 19215146 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT KNEE WAS INFECTED. PLOY WAS SWAPPED. SAME SIZE REPLACED. NO DEFECT WITH THE DEPUY PRODUCT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: JAN 9, 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18526312 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE CR RP CONSTRUCT DONE DUE TO LOOSENING AND INFECTION. THE SURGEON SAID THAT THE PATIENT EXPERIENCED PAIN FROM EARLY ON AFTER THE SURGERY SO SAID THEY PROBABLY GOT THE INFECTION FROM THE START. IMPLANTS WERE LOOSE AT THE CEMENT/BONE INTERFACE. SIMPLEX CEMENT WAS USED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17324473 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. SPACER PLACED WITH ANTIBIOTICS. CEMENT MANUFACTURER WAS COMPETITOR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17217920 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS PAIN/STIFFNESS AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Muscular Rigidity; Pain

  MAUDE report 14345432 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. REPLACED THE SAME SIZE POLY FOR A NEW ONE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10698157 ↗
• InjuryNov 20, 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 INSTABILITY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED GROSS LAXITY AND FLEXION PRIMARILY WITH A DEFICIENCY OF THE POSTERIOR CRUCIATE LIGAMENT. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9348211 ↗
• InjuryNov 18, 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, DECREASED RANGE OF MOTION, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014 DOR: (B)(6) 2016 LEFT KNEE.

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

  MAUDE report 9337381 ↗
• InjuryNov 4, 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 LEFT KNEE REVISION DUE TO PAIN, METAL ALLERGY TO NICKEL, ADHESIONS, AND TIBIAL TRAY LOOSENING 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) 2017. DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9273823 ↗
• InjuryApr 30, 2019Naturally Worn; Naturally Worn

  RIGHT KNEE. REASON FOR REVISION: PAIN. UPON OPENING THE KNEE THERE WERE SIGNS OF INFECTION. SAMPLES WERE SENT TO THE LAB FOR EXAMINATION. ALL IMPLANTS WERE FOUND TO BE WELL FIXED BUT WERE REMOVED. THE KNEE WAS THOROUGHLY WASHED OUT AND AN INTERIM PROSTHESIS CEMENTED IN WITH GENTAMICIN CEMENT MIXED WITH VANCOMYCIN. THE TIBIAL INSERT WAS RETAINED AND DECONTAMINATED. IT SHOWS EVIDENCE OF PUTTING AND THE SURGEON WOULD LIKE IT EXAMINED AND REPORTED ON. IT IS AVAILABLE FOR RETURN. ALL OTHER IMPLANTS HAVE BEEN DISCARDED.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8566542 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  ATTUNE CR RP REVISION FOR PAIN/STIFFNESS.

  Patient problems: No Code Available; Pain

  MAUDE report 8524551 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. ORIGINAL ATTUNE CEMENTLESS CR RP IMPLANTS WERE IMPLANTED ON (B)(6) 2018 BY DIFFERENT SURGEON.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8160079 ↗
• InjuryNov 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8103724 ↗