ATTUNE 1518-20-029Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295056669), received between Nov 4, 2017 and Jun 15, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25503647 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22233864 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PATELLA PAIN POST REVISION TKA UTILIZING AN LPS DISTAL FEMORAL COMPONENT. SOME PATELLAR BAJA IS NOTED VIA X-RAYS BUT THIS IS NOT UNCOMMON POST REVISION TKA AND SURGEON FELT THE PLACEMENT OF JOINT LINE WAS ACCEPTABLE. PATELLAR COMPONENT IS WELL FIXED AND ALL COMPONENTS ARE FUNCTIONING IN AN ACCEPTABLE MANNER, HOWEVER, SCAR TISSUE WAS NOTED AROUND THE PATELLAR COMPONENT. SCAR TISSUE WAS REMOVED BUT SURGEON COULD STILL FEEL SOME IRREGULAR FEELINGS AROUND THE PATELLA WITH FLEXION. HE THEN CHOSE TO REMOVE THE FEMORAL COMPONENT AND INCREASE EXTERNAL ROTATION. THIS SEEMED TO HELP TRACKING BUT HE WAS STILL NOT SATISFIED THAT THIS WOULD MAKE THE PATIENT HAPPY AND ULTIMATELY CHOSE TO REMOVE THE PATELLAR COMPONENT. AT THIS POINT, HE FELT HE HAD ADDRESSED HER CONCERN. HE CHOSE TO REPLACE THE DISTAL FEMORAL COMPONENT AND INSERT. THERE WERE NO ALLEGATIONS AGAINST ANY COMPONENT, THESE WERE SIMPLY EXCHANGED OR REMOVED AS THE SURGEON FELT THIS WAS IN THE PATIENTS BEST INTEREST. NO DELAY NOR PATIENT HARM TOOK PLACE DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 20345758 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED PATELLA AND INSERT, DID A WASHOUT AND PUT IN NEW IMPLANTS. UNKNOWN SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOR: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 16876029 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS AN ABRASION ON THE FOOT THAT WAS LEFT UNTREATED AND BECAME SWOLLEN. THE TREATMENT FOR INFECTION WAS REMOVAL OF THE IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC CEMENT MOLD. THE PATERA WAS NOT EXTRACTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16752734 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 9 MAR 2023. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Fatigue; Pain

  MAUDE report 16681594 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT INFECTION IS THE REASON FOR LOOSENING.

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

  MAUDE report 11418967 ↗
• InjurySep 3, 2020Malposition of Device; Malposition of Device

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO EFFUSION, KELOID REMOVAL, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. THE SURGEON INDICATED THE PATELLA COMPONENT WAS EVERTED AND ASSESSED TO HAVE AN ASYMMETRIC CUT, CONFIRMED BY X-RAY. HOWEVER, THE PATELLAR CUT WAS SO THIN ALREADY THAT THE SURGEON DECIDED NOT TO REVISE THE PATELLAR COMPONENT FOR FEAR OF CAUSING A DEVASTATING COMPLICATION. THE PATELLAR AND FEMORAL COMPONENTS WERE WELL-FIXED AND RETAINED. DOI: (B)(6) 2016, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Edema; No Code Available; Scar Tissue

  MAUDE report 10488176 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SALES REP WAS NOTIFIED THAT THE PATIENT HAD AN INFECTED LEFT KNEE. THE SURGICAL REMOVAL OF IMPLANTS WAS PLANNED FOR ON AN URGENT BASIS ON THIS DAY. SURGERY WAS PERFORMED IMPLANTS WERE REMOVED AND A PROSTALAC KNEE SPACER WAS IMPLANTED. DOI: (B)(6) 2018, (B)(6) 2019 (INSERT). DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9907895 ↗
• InjuryDec 2, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Malposition of Device; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, PATELLA MALTRACKING, CREPITUS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS NOTED TO TRACK WITH SIGNIFICANT LATERAL TILT AND THERE WAS CONTACT OF THE LATERAL PATELLA BONE WITH THE FEMORAL COMPONENT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 9395953 ↗
• InjuryOct 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 02 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING AND PAIN. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS LOOSE AND ABOUT TO COME OUT. HE REPORTED THE PATELLAR BUTTON CAME OFF VERY EASILY AND WAS REVISED. THERE WERE NO CONCERNS WITH THE FEMORAL COMPONENT, YET IT WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2018, (RT KNEE).

  Patient problems: Pain

  MAUDE report 9238264 ↗
• InjuryAug 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT UNDERWENT A FIRST-STAGE LEFT KNEE REVISION DUE TO INFECTION, PAIN, SWELLING, ERYTHEMA, AND FEVERS. THE SURGEON NOTED GROSS PURULENCE ENCOUNTERED UPON ENTERING THE KNEE. THERE WAS SIGNIFICANT SUBSIDENCE OF THE FEMORAL COMPONENT AND TIBIAL TRAY. THE FEMORAL COMPONENT, PATELLA COMPONENT, AND TIBIAL TRAY WERE ALL GROSSLY LOOSE AT BOTH THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. THE SURGEON REPORTED OSSEOUS EROSIVE CHANGES ON BOTH FEMORAL AND TIBIAL SIDES. THE SURGEON PLACED AN ANTIBIOTIC SPACER AND PERFORMED AN IRRIGATION AND DEBRIDEMENT. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Erythema; Fever; Injury; No Code Available; Osteolysis; Pain; Swelling; Unspecified Infection

  MAUDE report 8917013 ↗
• InjuryAug 6, 2019Fracture; Fracture

  PT HAD BILATERAL ATTUNE TKR 2017 BY REGISTRAR AT (B)(6) HOSPITAL. CR FEMUR 4, FB TIBIA 3, INSERT 5MM, 29MM DOME PATELLA. PT FELL. RESULTING IN RIGHT PATELLA FRACTURE. THIS WAS REVISED TODAY AND 32MM ATTUNE DOME PATELLA IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8865788 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  RECEIVED MEDICAL RECORDS ON 06/11/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. LEFT ATTUNE TOTAL KNEE REVISED TO ADDRESS PAIN, AND ASEPTIC LOOSENING OF THE TIBIAL BASE PLATE IDENTIFIED BY RADIOGRAPHS. REVISING SURGEON NOTED THAT THE FEMUR WAS WELL-FIXED, BUT TIBIAL BASE PLATE WAS NOTABLY LOOSE, LIFTING OUT OF THE CEMENT MANTLE. ALSO NOTED MEDIAL SUBSIDENCE OF THE TIBIA, AND MEDIAL OSTEOLYSIS AND OSTEONECROSIS BENEATH THE TIBIAL CEMENT MANTLE. FEMUR AND PATELLA WERE RETAINED; TIBIAL BASE PLATE AND INSERT WERE REVISED. DEPUY CEMENT WAS USED FOR PRIMARY. DOI: (B)(6) 2016; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: No Code Available; Not Applicable; Osteolysis; Pain

  MAUDE report 7731299 ↗
• InjuryNov 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATELLA WAS ALTA CHANGED FROM A CR FEMUR TO PS FEMUR AND RESECTED MORE DISTAL BONE.

  Patient problems: Ambulation or Postural Difficulties; Limited Mobility Of The Implanted Joint

  MAUDE report 7002192 ↗