ATTUNE 1506-00-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295042440), received between Jul 7, 2017 and Oct 27, 2020 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2016. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10740742 ↗
• InjuryDec 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS LOOSE WITH FRAGMENTED CEMENT AND SYNOVITIS. HE NOTED THE FEMORAL AND PATELLAR COMPONENTS WERE SOLID AND NOT REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY TIBIAL REVISION SYSTEM AND DEPUY CEMENT X 1. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2014; DOI: (B)(6) 2016; (RT KNEE).

  Patient problems: No Code Available; Pain; Synovitis

  MAUDE report 9409734 ↗
• InjuryOct 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE CASE WAS SCHEDULED AS A POLY EXCHANGE VS FULL REVISION. WHEN THE SURGEON WENT TO TEST THE STABILITY OF THE IMPLANTS, THE TIBIAL TRAY BECAME LOOSE AFTER A FEW SUTTLE BLOWS FROM AN OSTEOTOME/MALLET. THE FEMORAL COMPONENT AND THE TIBIAL INSERT WERE ALSO EXTRACTED. THE PATELLA COMPONENT WAS RETAINED. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9219133 ↗
• InjuryJun 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 23 JUL 2018. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. PATIENT UNDERWENT A LEFT TKA WITH DEPUY CEMENT. THE PATELLA WAS NOT RESURFACED. THE PATIENT THEN UNDERWENT A REVISION FOR PAIN AND TIGHTNESS. INTRAOPERATIVE FINDINGS INCLUDED CHRONIC INFLAMMATION, TIGHTNESS/SCARRING REQUIRING A QUADRICEPS SNIP FOR BETTER VISUALIZATION, LOOSENING OF THE TIBIAL TRAY AT IMPLANT-CEMENT INTERFACE, AND A PITTED INSERT. DOI: (B)(6) 2015; DOR: (B)(6) 2017, (LEFT).

  Patient problems: Inflammation; No Code Available; Pain; Scarring

  MAUDE report 8718246 ↗
• InjuryJul 2, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER. DOI: (B)(6) 2017; DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7654561 ↗
• InjuryMay 10, 2018Loss of or Failure to Bond; Insufficient Device Problem Information; Loss of or Failure to Bond; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Fibrosis; No Code Available; Not Applicable; Pain; Scarring

  MAUDE report 7502276 ↗
• InjuryFeb 21, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL BASE PLATE LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2014; DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7285665 ↗
• InjuryJul 7, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PATELLA, FEMORAL, AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6692580 ↗