ATTUNE 1516-30-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295048145), received between Nov 29, 2021 and Aug 12, 2024 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PUT THE LEG THROUGH A RANGE OF MOTION RIGHT BEFORE CLOSING AND FELT THAT INCREASING THE POLY THICKNESS BY 2MM WOULD MAKE THE KNEE MORE STABLE THAN IT WAS ALREADY AND THE BEST POSSIBLE OUTCOME FOR THE PATIENT. THEY SWAPPED THE POLY QUICKLY AND SURGEON PUT THE LEG THROUGH A RANGE OF MOTION WITH THE NEW THICKER POLY AND SATISFIED WITH THE STABILITY OF THE KNEE. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19960583 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STARTUP PAIN. TIBIA REVISION WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17754989 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A SECOND WASHOUT FOR THIS PATIENT. ALL COMPONENTS WERE REMOVED AND THE JOINT WASH THOROUGHLY WASHED OUT. AN ALL POLY IMPLANT WAS PLACED WITH ANTIBIOTIC CEMENT AS A SPACER. NO OTHER INFORMATION. NO DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16395698 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. RIGHT KNEE. REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 14211947 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLEASE SEE PREVIOUS PC'S FOR THIS PATIENT AS THIS IS THE 3RD REVISION FOLLOWING THE PRIMARY. PATIENT HAS NOW PRESENTED WITH A SWOLLEN, HOT AND PAINFUL KNEE. ON OPENING THE KNEE THE WAS IF YES, PLEASE DESCRIBE: INFECTION, HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION, REASON FOR REVISION SURGERY: REMOVAL, WASHOUT AND NEW BEARING.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13063675 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE AN ATTUNE CR WAS UTILISED ((B)(6) 2016 - PATIENT HAD HAD OSTEOMYELITIS). A REVISION WAS PERFORMED TO REMOVE A LOOSE TIBIAL TRAY AND AN ATTUNE REVISION RP TRAY, SLEEVE AND STEMS WAS UTILISED ((B)(6) 2019 SEE (B)(4)). PATIENT HAS DONE WELL FOR ALMOST 2 YEARS AND HAS NOT PRESENTED WITH TIBIAL SHIN PAIN. BONE SCANS SHOW AN UPTAKE UNDER THE TIBIAL TRAY AND AT THE TI- OF THE STEM. A DECISION WAS MADE TO RE REVISE (2ND REVISION) THE TIBIAL TRAY. ON OPENING THE KNEE ((B)(6) 2021) THE ORIGINAL CR FEMUR WAS FOUND TO BE WELL FIXED. THE REVISED TIBIAL TRAY ALSO APPEARED WELL FIXED AND IT REQUIRED LOTS OF WORK TO REMOVE. THE SLEEVE HAD EXTENSIVE BONE ONGROWTH. A NEW STEM, LARGER SLEEVE AND A NEW TIBIAL TRAY WERE IMPLANTED ALONG WITH A NEW CR RP INSERT - TO MATCH THE CR FEMUR. DOI: (B)(6) 2016. DOR: (B)(6) 2019. DOR: (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12883524 ↗