ATTUNE 1516-50-910Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295053026), received between Oct 16, 2018 and Dec 31, 2025 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR PAIN.

  Patient problems: Pain

  MAUDE report 23935313 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. IMPLANTS WERE REMOVED DUE TO INFECTION OF THE KNEE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE DUE TO THE SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 21162055 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT HAD INFECTED ANKLE AND INFECTED KNEE. SURGEON KEPT EXISTING COMPONENTS AND EXCHANGED POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17002772 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE CLARIFY, WHAT WERE THE PRODUCTS REMOVED DUE TO INFECTION? BASED ON THE IMPACTED PRODUCTS REPORTED, ONLY THE PRODUCT RETURN STATUS OF THE TIBIAL INSERT WAS DISCARDED. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S). IF YES, PLEASE PROVIDE DETAILS. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. CAN YOU PLEASE PROVIDE THE LOT NUMBER FOR THE REPORTED PRODUCTS (ATTUNE PS FEM RT SZ 9 CEM) AND (ATTUNE MEDIAL DOME PAT 41MM)? PATIENT DEMOGRAPHICS & COMORBIDITIES. RADIOGRAPHS/X-RAY FILMS AND OP NOTES IF AVAILABLE. RESPONSE: I HAVE PROVIDED ALL THE INFORMATION AVAILABLE. THE ONLY IMPLANT REVISED WAS THE BEARING AS IT IS A WASHOUT OR DAIR PROCEDURE FOR INFECTION AS REPORTED. DAIR IS DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION, A PROCEDURE FOR INFECTION WHILE RETAINING THE PROTHESIS. IT IS A COMMON ANACRONYM FROM THE PAST FIVE YEARS. THE IMPLANTS WERE MARKED UNAVAILABLE IMPLANTED WHICH WAS FOR ALL EXCEPT THE BEARING WHICH WAS DISCARDED TO ALLOW THOROUGH IRRIGATION OF THE JOINT. I DO REM

  Patient problems: Unspecified Infection

  MAUDE report 14043763 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. ORIGINAL PROSTHESIS WAS REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13654511 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT TOTAL KNEE THAT IS INFECTED. THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED TEMPORARY PARTS. ALL COMPONENTS WERE WELL FIXED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12200685 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS NOTED TO BE SCAR REMOVAL. THE SURGEON ALSO NOTED MINIMAL BONE LOSS WITH REMOVAL OF THE WELL-FIXED FEMORAL COMPONENT. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11463674 ↗
• InjuryNov 24, 2020Adverse 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 INFECTION. ONE STAGE REVISION WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1516-50-910 WAS IMPLANTED ON (B)(6) 2020. DOI: (B)(6) 2020, DOI (INSERT): (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10898143 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. I & D AND POLY EXCHANGE PERFORMED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10200661 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO LOOSENING AND NO SURGICAL DELAY REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9856478 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN/DISCOMFORT. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8650807 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8181019 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR I&D OF THE RIGHT TOTAL KNEE WITH POLY EXCHANGE DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7969020 ↗