ATTUNE 1506-10-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295042648), received between Aug 7, 2017 and Dec 21, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL AND PATELLAR COMPONENTS WERE RETAINED. THE TIBIAL INSERT WAS REVISED WITH NO ALLEGED DEVICE DEFICIENCY. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11047759 ↗
• InjurySep 29, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  TIBIA LOOSENING. REVISION SURGERY TUESDAY (B)(6) 2020. ORIGINAL SURGERY DATE (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 10600087 ↗
• InjuryAug 19, 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 IS UNKNOWN. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10426222 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF ADHESION TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFFNESS. THERE WAS NO ADHERENCE AT THE FEMORAL - CEMENT TO IMPLANT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015 (TIBIAL TRAY, CEMENT, PATELLA AND FEMORAL COMPONENT); DOI: (B)(6) 2016 (TIBIAL INSERT); DOR: (B)(6) 2018 (LEFT KNEE).

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

  MAUDE report 9497841 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF SCAR TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFF AND DIFFICULT TO FLEX UP. THE SURGEON REPORTED THE FEMORAL COMPONENT WAS FOUND TO BE VERY LOOSE AND TAMPED OFF WITH NO BONE LOSS. THERE WAS NO ADHERENCE AT THE FEMORAL COMPONENT TO CEMENT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. PRIMARY PRODUCT INFORMATION CAN BE FOUND ON PAGE 8/17 OF THE MEDICAL RECORDS. TWO DEPUY CEMENT PRODUCTS WERE USED DURING PRIMARY OPERATION. PLEASE ADD HOSPITAL ACCOUNT INFORMATION. AWARENESS DATE IS (B)(6) 2019.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9497251 ↗
• InjuryOct 30, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 07 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND DEPUY BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING, SWELLING, AND PAIN. THE SURGEON INDICATED THE REMOVAL OF SCAR AND ADHESIVE TISSUE AROUND THE PATELLA AND LATERAL CAPSULE. HE REPORTED THE TIBIAL BASEPLATE WAS LOOSE. HE REPORTED THE FEMORAL COMPONENT TO BE TIGHT WITHOUT ANY MOTION, THOUGH WAS REVISED. THE SURGEON DID NOT COMMENT ON THE PATELLA, THOUGH IT WAS REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND UNKNOWN CEMENT. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2018, (LT KNEE).

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

  MAUDE report 9256845 ↗
• InjuryOct 8, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  RIGHT REVISION TO ADDRESS PAIN, INSTABILITY, QUAD ATROPHY AND QUAD WEAKNESS, EFFUSION, AND LOOSENING OF THE TIBIAL COMPONENT AT THE IMPLANT/CEMENT INTERFACE. THERE WAS WEAR WITH GROOVING AND PITTING TO THE UNDERSIDE OF THE ROTATING PLATFORM. THERE WERE CRACKS IN THE CEMENT AND A SMALL CRACK IN THE MEDIAL CONDYLAR REGION, NOT COMPLETE, BUT CONSISTENT WITH PROBABLE STRESS FRACTURE. PATELLA WAS NOTED TO BE OVERSTUFFED.

  Patient problems: Bone Fracture(s); Edema; No Code Available; Pain; Swelling; Weakness

  MAUDE report 7944743 ↗
• InjuryMay 30, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING. TIBIA CAME OUT CLEAN. LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER USED WAS OF COMPETITOR. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Joint Disorder; No Code Available; No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7552754 ↗
• InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6772289 ↗