ATTUNE 1504-00-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295041108), received between Jul 7, 2017 and Jul 15, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 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.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI-UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25828335 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED MULTIPLE INFECTIONS AND WASH OUTS. ON (B)(6) 2025 THE PATIENT UNDERWENT A RESECTION ARTHROPLASTY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23942811 ↗
• InjuryApr 25, 2025Adverse 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 OF TOTAL KNEE ARTHROPLASTY. PATIENT WAS TREATED BY REMOVING ALL IMPLANTS, PERFORMING A DEBRIDEMENT, AND PLACING A FEMUR AND ALL POLY TIBIA IN AS A SPACER WITH ANTIBIOTICS IN THE JOINT. NOTHING FURTHER TO REPORT. THERE WAS NO SURGICAL DELAY AND NO LOOSENING. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21908559 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED BILATERAL TKA. FOLLOWING SURGERY, PATIENT WAS SATISFIED WITH RIGHT SIDE. HOWEVER LEFT SIDE HAS GIVEN CONSISTENT PAIN ISSUE EVER SINCE OPERATION. NO VISIBLE LOOSENING ON X-RAY AND NO EVIDENCE OF INFECTION. DECISION WAS MADE TO REVISE LEFT TKA TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 18856138 ↗
• MalfunctionOct 27, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  WHAT I CAN REMEMBER IT WAS JUST THE PRODUCT IN THE PICTURE WHICH WAS AFFECTED. I HAVE NO FURTHER INFORMATION. CAN IT BE VERIFIED HOW MANY DEVICES ARE AFFECTED BY THIS ISSUE?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021896 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED (FEMUR TRANSLATED ANTERIORLY). REVISED FEMUR TO CRS.

  Patient problems: Joint Dislocation

  MAUDE report 11404452 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STILL LEFT TOTAL KNEE ARTHROPLASTY/ADHESIONS; FAILURE TO PROGRESS IN PHYSICAL THERAPY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE) . TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s)

  MAUDE report 11148202 ↗
• InjuryJan 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 25 NOV 2019. MEDICAL RECORDS RECEIVED ON 25 NOVEMBER 2019 WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES ON 16 DECEMBER 2019. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING AND PAIN. THE SURGEON REPORTED A PATELLOPLASTY WAS ALSO PERFORMED WITH THE REMOVAL OF BONE SPURS. HE NOTED THE PATELLAR COMPONENT WAS WELL FIXED AND WELL POSITIONED AND WAS DEBRIDED. THE SURGEON REPORTED A SYNOVECTOMY OF SOME TISSUE THAT WAS CONSISTENT WITH OSTEOLYSIS. HE INDICATED THE FEMORAL COMPONENT APPEARED LOOSE WITH MOTION AND SOME AREAS DID NOT RETAIN MUCH CEMENT. THE SURGEON REPORTED THE TIBIAL COMPONENT HAD MOTION BETWEEN THE COMPONENT MEDIALLY ANT THE BONE. BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED, AND THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDUR

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9564173 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, 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 SMARTSET BONE CEMENT X 3. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LIGAMENTOUS INSTABILITY, EFFUSIONS, LIMITED MOTION, AND TIBIAL LOOSENING. THE SURGEON INDICATED THE TIBIAL COMPONENT HAD COMPLETELY DE-BONDED FROM THE TIBIA CEMENT LEAVING 100% OF THE CEMENT INTACT WITH THE BONE INTERFACE. LOOSENING AT THE TRAY/CEMENT INTERFACE. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH RECIPROCATING SAW AND OSTEOTOME. THE SURGEON REPORTED THE PATELLA WAS REVISED TO REDUCE THE THICKNESS FOR IMPROVED FLEXION. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2018; DOR: (B)(6) 2019 (LT KNEE).

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9362498 ↗
• InjuryNov 18, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND DEPUY BONE CEMENT X 3. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, INSTABILITY, CREPITUS/CLUNK, AND PAIN. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS REMOVED WITH MINIMAL EFFORT AND WAS COMPLETELY DE-BONDED FROM THE CEMENT MANTLE. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH MODEST EFFORT AND MINIMAL BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS REVISED IN THE PROCEDURE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND DEPUY BONE CEMENT X 3. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2018 (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9338053 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE.

  Patient problems: No Code Available; Pain; Scarring

  MAUDE report 8016135 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED DUE TO CONTINUED PAIN. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Pain

  MAUDE report 7621017 ↗
• 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 6692544 ↗