ATTUNE 1506-60-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295042914), received between Aug 9, 2018 and Sep 17, 2026 — classified as 60 injuries, 2 malfunctions.

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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Difficult to Open or Remove Packaging Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809524 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION PROCEDURE DUE TO PERSISTENT INFECTION FOLLOWING A PREVIOUS TWO-STAGE REVISION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED, AND THEY WERE REPORTED TO BE WELL FIXED AT THE TIME OF REMOVAL. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 25552253 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24267290 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE OCCURRED DUE TO INFECTION. ORIGINAL SURGERY WAS DONE ABOUT TWO YEARS AGO. EXACT DATE UNKNOWN. RIGHT SIDE. COMPONENTS WERE WELL FIXED. ALL COMPONENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 24167091 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE RP BEARING WAS IN BACKWARD. IT IS UNKNOWN IF IT WAS IMPLANTED THIS WAY OR IT ROTATED INTO THAT ORIENTATION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24160421 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT STIFFNESS WITH ESSENTIALLY NO MOTION POST REVISION TKA FOR STIFFNESS. SURGEON IS NOT SURE WHY PATIENT IS SO STIFF AS NO INFECTION IS PRESENT BASED ON LABS AND FROZEN SECTION. ALL COMPONENTS WERE REMOVED. FEMORAL SLEEVE WAS NOT INGROWN ALMOST 5 MONTHS POST OP. THERE WAS NO RADIOGRAPHIC INDICATION THAT COMPONENT WOULD BE LOOSE. TIBIAL COMPONENTS WERE SUBSEQUENTLY REMOVED TO LOWER THE JOINT LINE AS THE PATELLA WAS IMPINGING THE INSERT AFTER REVISING THE FEMUR. THIS IS LIKELY A RESULT OF SHORTENING OF THE PATELLAR TENDON DUE TO LACK OF MOTION. TIBIAL SLEEVE WAS ONLY PARTIALLY INGROWN. NO DELAY NOR PATIENT HARM WAS NOTED. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23709354 ↗
• InjuryOct 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT ONE STAGE REVISION DONE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23390707 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23325369 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS INFECTED WITH MERSA SO ALL OF HER PREVIOUS IMPLANTS WERE TAKEN OUT TO BE REPLACED WITH ANTIBIOTIC SPACERS. NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 23290642 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612728 ↗
• InjuryJul 2, 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 PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22387114 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22026040 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST KNEE REPLACEMENT, AND HAD A PERIPROSTHETIC FRACTURE. IN A SEPARATE SURGERY, THEY ADDED A DISTAL FEMUR CONDYLAR PLATE. PATIENT FELL AGAIN, AND BROKE PROXIMAL TO THE PLATE. THE PLAN WAS TO REMOVE THE FEMUR, AND USE A DISTAL FEMUR REPLACEMENT. HOWEVER THE PATIENT HAS AN ACTIVE KNEE INFECTION, AND PUSS WAS IN THE SURGERY SITE. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 21962844 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTION AND DR. DECIDED TO REMOVE ALL EXISTING IMPLANTS AND PUT IN A TEMPORARY SPACER UNTIL INFECTION HAS CLEARED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6)2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20941955 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT AS PER SURGEON, THE PATIENT HAD NICKEL ALLERGY. SURGEON REMOVED ALL COMPONENTS AND PUT IN COMPETITOR'S NICKEL FREE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20831270 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT COMPLEX PRIMARY KNEE REPLACEMENT ON (B)(6) 2023 REQUIRING NOILES HINGE REPLACEMENT DUE TO MULTIPLE PREVIOUS LIGAMENT INJURIES. SUBSEQUENT TRAUMATIC PATELLA FRACTURE REQUIRING RECONSTRUCTION AND PRESENTED ON (B)(6) 2024 WITH PROSTHETIC JOINT INFECTION REQUIRING REMOVAL OF ALL COMPONENTS AND FUSION SPACER. IMPLANTS REVISED AND CEMENT SPACER IMPLANTED AS TEMPORARY MEASURE WHILST INFECTION TREATED.

  Patient problems: Unspecified Infection

  MAUDE report 20612162 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION DUE TO INSTABILITY DEVICE RELATED: NO INFORMATION PROVIDED PROCEDURE RELATED: NO INFORMATION PROVIDED DATE OF EVENT: SEPTEMBER 17, 2024 DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: (B)(6) 2024 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: : BLOOD THINNERS (ASPIRIN) AND TED HOSE. TREATMENT/IMPACT: : INFORMATION NOT PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20438457 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352459 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SEPSIS. DEVICE RELATEDNESS: NO INFORMATION PROVIDED. PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK (B)(6) 2024, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333272 ↗
• InjurySep 19, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: Fall; Pain

  MAUDE report 20258457 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019 DATE OF EVENT (ONSET): 07/03/2020 (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20031802 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE (ONGOING). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2020 (I&D WITH TIBIAL INSERT EXCHANGE). DATE OF EVENT (ONSET): 09/08/2020. (LEFT KNEE). TREATMENT: ASPIRATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 20031299 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT. REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED. DOI: (B)(6) 2024. DOE: (B)(6) 2024. ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION. REVISED TO SROM HINGE. PERSISTENT INFECTION. RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19749544 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT: ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO PAIN, AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (B)(4) . AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021 DOR: (B)(6) 2022. (B)(4). AFFECTED SIDE: RIGHT KNEE (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19323103 ↗
• InjuryMay 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA WAS DEEMED TO BE LOOSE. THE LOOSENING WAS AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS COMPETITOR. DOI: (B)(6), 2022 DOR: (B)(6), 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19280473 ↗