ATTUNE 1513-14-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 10603295043607), received between Nov 26, 2018 and Sep 25, 2026 — classified as 112 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904677 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904668 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to insufficient mcl and surgeon put in a hinge.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected side: Right knee.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50119287 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THESE PRODUCTS IMPLANTED ON (B)(6) 2026. LATER THAT NIGHT IN THE PACU PATIENT SUSTAINED A KNEE DISLOCATION, REASONS UNKNOWN. THERE WAS NO EVENT THAT TRIGGERED IT. ACCORDING TO THE DR. ¿IT JUST SORT OF HAPPENED WITHOUT AN INCIDENT¿. THE DR STATS THAT THE PATIENT HAD A HISTORY OF COMPROMISED SOFT TISSUES OF THE LEFT KNEE. SO THE DR EXPLANTED ALL COMPONENTS AND IMPLANTED A HINGE KNEE REVISION PROSTHESIS. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) WAS CREATED TO CAPTURE ADDITIONAL IPS.

  Patient problems: Joint Laxity

  MAUDE report 25872369 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25871310 ↗
• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT DEVICES THAT WERE IMPLANTED IN (B)(6) 2025 ARE STILL IMPLANTED IN THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25176973 ↗
• 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 24267375 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE PRESSFIT STR STEM14X60MM, ATUN TIB SLV M/L 45MM FULL POR, ATUNE REV RP TIB BASE SZ 4 CEM, ATTUNE REV LPS INSRT XXSM 12MM, LPS DISTAL FEM COMP XXSM RT, ATT REV SLV LPS FEM ADP +5, ATUN FEM SLV M/L 45MM FULL POR, AND ATUN PRESSFIT STR STEM12X110MM WERE INVOLVED IN A REPORTED EVENT. THE PATIENT, WHO HAD PREVIOUSLY RECEIVED A REVISION KNEE POST SPACER FOR INFECTION, PRESENTED WITH WOUND DRAINAGE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND THOROUGH DEBRIDEMENT AND IRRIGATION WERE PERFORMED. A NEW SPACER WAS FASHIONED USING LPS COMPONENTS, RESORBABLE ANTIBIOTIC BEADS, AND HIGH-DOSE ANTIBIOTIC CEMENT. NO DEVICE MALFUNCTION WAS ALLEGED, AND ALL COMPONENTS WERE REPORTED TO BE FUNCTIONING AS EXPECTED. THE TIBIAL COMPONENT WAS WELL FIXED, AND THE EVENT WAS ATTRIBUTED TO INFECTION RATHER THAN DEVICE FAILURE. ALL LISTED PRODUCTS WERE EXPLANTED DURING THE PROCEDURE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24257849 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24162435 ↗
• 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 24161051 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4) WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697832 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4), WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697814 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607669 ↗
• InjuryNov 13, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION ¿ ASEPTIC LOOSENING DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 20 OCT 2025 DATE OF IMPLANT: (B)(6) 2014 DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION - COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL, TRUE), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23547685 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404488 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404459 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PROGRESSIVE LUCENT LINES AROUND COMPONENTS AND PAIN, SUGGESTING FAILED FIXATION. IMPLANTS WERE REMOVED UNEVENTFULLY AND REIMPLANTED WITH NEW COMPONENTS. FROZEN SECTION WAS NEGATIVE FOR INFECTION. CEMENT HAD NOT ADHERED TO THE BONE, BUT THE TIBIAL SLEEVE WAS WELL FIXED AND THUS LEFT IN PLACE. THE FEMORAL COMPONENTS HAD BEEN REVISED ON (B)(6) 2024 FOR FAILED INGROWTH AND A CEMENTED STEM WAS PLACED AT THAT TIME. POLY WAS REVISED (B)(6) 2024 WHEN EXCESSIVE SCAR TISSUE WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23380104 ↗
• InjuryOct 23, 2025Adverse 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 POST-OPERATIVE ANEMIA. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 15 FEB 2020. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: 2 X ERYTHROCYTE CONCENTRATE.

  Patient problems: Anemia

  MAUDE report 23368129 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL-FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH HAD OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011425 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853675 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22852774 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES, SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828086 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828046 ↗
• 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: JULY 9, 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612773 ↗
• 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 22387118 ↗