ATTUNE 1516-50-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295052487), received between Jun 6, 2018 and Dec 31, 2025 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) 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 INFECTION. THE ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS MINOR YELLOWING".

  Patient problems: Unspecified Infection

  MAUDE report 23934704 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO FELL. PATIENT DISLOCATED PS FEMUR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21114173 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFF KNEE, SURGEON DOWNSIZED POLY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 19721179 ↗
• InjuryApr 15, 2024Adverse 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 INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 19104848 ↗
• InjuryApr 11, 2024Adverse 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 INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 19088903 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. SURGEON UPSIZED POLY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18862868 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. WASHOUT THE IMPLANT THROUGH SURGERY. DOI: UNKNOWN. DOR: (B)(6), 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15066633 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 13 SEP 2018. RECORDS INDICATE PATIENT RECEIVED AN ATTUNE TKA. NO ALLEGATIONS PROVIDED OF PATIENT INJURY OR PRODUCT FAILURE, NOR REPORT OF REVISION. THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 UTILIZING DEPUY SYNTHES COMPONENTS INCLUDING PATELLA RESURFACING WITH A COMPETITOR CEMENT WITH NO COMPLICATIONS. ON (B)(6) 2016, SHE UNDERWENT A REVISION FOR ASEPTIC FAILURE OF THE LEFT TKA. INTRAOPERATIVELY, EXTENSIVE SCARRING WAS FOUND. THE SURGEON REQUIRED OSTEOTOMES TO REMOVE THE FEMORAL AND TIBIAL COMPONENTS AND ANY INDICATION OF LOOSENING WAS NEVER STATED. THE SURGEON STATES THAT 6 DEGREES OF EXTERNAL ROTATION FROM THE PREVIOUS EXTERNAL ROTATION WAS CUT TO "IMPROVE THE ALIGNMENT OF THE FEMORAL COMPONENT." NO OTHER COMPLICATIONS IDENTIFIED. DOI: (B)(6) 2015, DOR: UNKNOWN (LEFT).

  Patient problems: Adhesion(s)

  MAUDE report 12474119 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AND INFECTION FOR UNKNOWN REASONS. COMPONENTS WERE EXPLANTED AND ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2021, DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12306504 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS SCAR REMOVAL, SEVERE FEMORAL AND TIBIAL BONE LOSS, AND TIBIAL TRAY LOOSENING AND MIGRATION. THE FEMORAL COMPONENT WAS NOTED TO BE WELL-FIXED WITH NO MENTION OF MIGRATION. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND CEMENT ALONG WITH A COMPETITOR TIBIAL CONE. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 11752991 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND DRAINING KNEE AFTER FALLING. I & D AND POLY SWAP WERE PERFORMED ON (B)(6). PATIENT HAD A RT TKA ON (B)(6) 2020. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Fall; No Code Available; Unspecified Infection

  MAUDE report 10662299 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKA REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Deformity/ Disfigurement; No Code Available

  MAUDE report 9765789 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SECOND REVISION OF THE LEFT KNEE ON (B)(6) 2018 SECONDARY TO CONTINUED SYMPTOMS OF PAIN AND SWELLING. INTRAOPERATIVELY, THE SURGEON IDENTIFIED CEMENT-DEBRIS SYNOVITIS; EXCESSIVE FIBROUS TISSUE; SEVERE BONE LOSS TO THE MEDIAL TIBIA; AND THE TIBIAL COMPONENT WAS GROSSLY LOOSE, INTERFACE UNKNOWN. THE PATELLAR COMPONENT WAS RETAINED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

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

  MAUDE report 9553015 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGED THAT PATIENT SUSTAINED PERSONAL INJURY AS A RESULT OF IMPLANTATION OF A DEFECTIVE DEPUY ATTUNE KNEE DEVICE. DOI: (B)(6) 2015, DOR: NOT REPORTED UNKNOWN KNEE.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 9426187 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8317160 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS RIGHT KNEE WAS REVISED DUE TO INFECTION. INCISION AND DEBRIDEMENT WASHOUT WAS PERFORMED. THE POLY EXCHANGE TOOK PLACE. DOI: (B)(6) 2018 DOR: (B)(6) 2018 RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7845503 ↗
• InjuryJun 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT I AND D WITH POLY EXCHANGE WAS PERFORMED. AT THE TWO WEEKS POST OPERATIVE VISIT, STAPLES WERE REMOVED AND THE INCISION LOOKED NORMAL. THE INCISION BEGAN TO DRAIN AND THE SURGEON OPTED FOR I AND D WITH POLY EXCHANGE. INTRA-OP SPECIMENS RETURNED POSITIVE FOR INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7572789 ↗