ATTUNE 1513-18-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295043737), received between Jan 22, 2020 and May 18, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Migration

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE ER WITH POOR FUNCTION AND PAIN. FEMORAL COMPONENT APPEARED TO HAVE ROTATED ROUGHLY 90 DEGREES INTERNALLY. THE STEM, SLEEVE AND LPS ADAPTER WERE PLACED INITIALLY AND LEFT IN PLACE WHEN CONVERTED FROM A SPACER TO A REV TKA USING AN IPS DISTAL FEMUR ON (B)(6) 2026. THERE APPEARED TO BE DAMAGE ON THE TAPER OF THE ADAPTER AND UNFORTUNATELY IT COULD NOT BE REMOVED. THE STEM, SLEEVE AND ADAPTER WERE ALL REMOVED AND NEW COMPONENTS WERE PLACED WITH NO DELAY NOR PATIENT HARM. DOIL: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25205176 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24367209 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730712 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS HAD FIVE PRIOR KNEE REVISION PROCEDURES ON THIS KNEE. DURING THIS PROCEDURE, THE PATIENT'S REVISION COMPONENTS WERE REMOVED DUE TO INFECTION. A STATIC SPACE, MADE OF ANTIBIOTIC BONE CEMENT AND STEINMANN PINS, WERE IMPLANTED TO SPAN THE PATIENT'S KNEE UNTIL HER INFECTION HAS CLEARED. THERE WAS NO SURGERY TIME EXTENDED. DOI: (B)(6) 2023 (FEMORAL COMPONENTS) AND (B)(6) 2024 (TIBIAL COMPONENTS) DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21610765 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? RIGHT SIDE. C. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, IT WAS NOT. D. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO THERE WAS NOT. E. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, THEY WERE NOT. THE LAXITY IN FLEXION WAS BELIEVED TO BE SOFT TISSUE RELATED. F. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED, DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO, I DON¿T BELIEVE SO. AS THE FIRST REVISION ONLY USED AN 8MM POLY.

  Patient problems: Joint Laxity

  MAUDE report 19067456 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED SWELLING OF LEFT KNEE EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Swelling/ Edema

  MAUDE report 17488302 ↗
• InjuryMay 17, 2023Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THIS PATIENT IS VERY LARGE IS STATURE, HAS A BKA ON HIS CONTRALATERAL LIMB AND CONTINUES TO SMOKE. HE PRESENTS POST SURGICALLY WITH PAIN IN HIS THIGH. XRAYS SHOW THAT THE FEMORAL SLEEVE HAS NOT INGROWN AND THE STEM APPEARS TO BE BROKEN AT THE STEM-SLEEVE JUNCTION. OPERATIVELY, HIS IMPLANT WAS NOT INGROWN AND SHOWED SIGNIFICANT METALOSIS IN THE JOINT. TISSUE ARE SENT TO PATHOLOGY TO RULE OUT INFECTION. THE IMPLANT COULD BE SPUN AROUND ONCE THE INSERT WAS REMOVED AND THIS WAS CONCERNING. UPON CONTINUED EXPLORATION AND WITH REMOVAL OF THE FEMORAL IMPLANT, IT WAS FOUND THAT THE STEM- SLEEVE JUNCTION WAS LOOSE, NOT BROKEN. A THOROUGH DEBRIDEMENT IS PERFORMED AND A LONG BOWED CEMENTED LPS STEM WAS PLACED UNEVENTFULLY. THE NEW PIN THAT COMES WITH THE DISTAL FEMORAL COMPONENT WAS UTILIZED. NO INSTRUMENTS WERE BROKEN. DOI: (B)(6) 2021; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Pain

  MAUDE report 16947746 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6), AFFECTED SIDE : RIGHT KNEE .

  Patient problems: Unspecified Infection

  MAUDE report 16742921 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732432 ↗
• InjuryOct 21, 2022Osseointegration Problem; No Apparent Adverse Event; Osseointegration Problem; No Apparent Adverse Event

  REVISION OF DEPUY TKR COMPONENTS FOR IMPLANT LOOSENING. LEFT KNEE. LOT NUMBERS NOT SOURCED. IMPLANTS DISCARDED. DOI: (B)(6), 2009. DOR (12TH): (B)(6), 2021. DOR (13TH): (B)(6), 2022.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649686 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2021. THE REVISION DATE FOR THE LOOSENING AND INFECTION IS (B)(6) 2021. (THIS WAS DOCUMENTED IN THE EVENT DESCRIPTION AS (B)(6) 2021 BUT THIS WAS A CLERICAL ERROR). THE REVISION DATE FOR THIS PC IS (B)(6) 2021. ALL IMPLANTS WERE REVISED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14013123 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL IMPLANTS REMOVED SECONDARY TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13096494 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE CONFIRM PRESENCE OF INFECTION? BACTERIA HAVE BEEN GROWN FROM THE SAMPLES TAKEN AT THE TIME OF REMOVING THE ATTUNE REVISION. INDICATING AN INFECTION. 2. WAS LOOSENING, DUE TO INFECTION? YES. 3. IT WAS INDICATED, IN THE EVENT DESCRIPTION THAT "THE TIBIA APPEARS TO HAVE MOVED/ SUBSIDED ON THE MEDIAL SIDE. WITH THE LONG 160MM CANAL FILLING STEM (LONG STEM WAS REQUIRED TO BYPASS THE ORIGINAL STEM), ABUTTING THE LATERAL CORTEX. WHICH SHOWS SIGNS OF REMODELING". PLEASE CLARIFY, DID THE TIBIA SUBSIDE? YES IT DID. MOVING INTO VARUS WITH THE DISTAL TIP ABBUTTING THE DISTAL LATERAL CORTEX. 4. CAN YOU PLEASE ADVISE, WHO THE MANUFACTURER OF THE PATELLA WAS. I WOULD GUESS, IT WAS A ZIMMER BIOMET PATELLA.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12780579 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY SECONDARY TO ASEPTIC LOOSING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12275557 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SPIRAL FRACTURE OF THE FEMUR STARTING AT THE PROXIMAL TIP OF THE ATTUNE PRESS FIT FLUTED STEM. ATTUNE KNEE REVISION WAS PERFORMED ON 5/20. CASE WENT WELL AND SURGEON WAS CONTACT WITH OUTCOME. ATTUNE REVISION SURGICAL TECHNIQUE WAS FOLLOWED PERFECTLY. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11992182 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE INFECTIONS AT THE UNKNOWN CAUSES. DOI: (B)(6) 2019; (B)(6) 2020 (POLY EXCHANGE DUE TO INSTABILITY CAPTURED IN (B)(4)) DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11171607 ↗
• InjuryApr 16, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL STEM WENT THROUGH FEMORAL CANAL. REPLACED WITH SHORTER STEM. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Injury; No Code Available

  MAUDE report 9967581 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED LOOSE ATTUNE TRAY (B)(6) 2019 - REPLACED WITH STEMMED TIBIA AND CAPTURED IN (B)(4). IT WAS ALSO REPORTED THAT THE PATIENT IS MISERABLE WANTED ALL COMPONENTS REMOVED. THEY PLANNED A TC3 RP. FEMORAL COMPONENT IN TOO MUCH VALGUS. PATELLA, FEMUR, POLY AND TIBIA WERE REMOVED. TC3 CP - RESULT LESS VALGUS - BALANCED WELL, PATELLA TRACKED WELL. THERE WAS A SURGICAL DELAY OF 80 MINS. DOI: (B)(6) 2019 (TIBIAL TRAY, INSERT AND PRESSFIT STEM), (B)(6) 2018 (PATELLA AND FEMORAL). DOR: (B)(6) 2019, LEFT KNEE.

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

  MAUDE report 9818134 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, DEPUY CEMENT WAS UTILIZED X3. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRIMARY IMPLANT INFORMATION LOCATED ON PAGE 8. ON (B)(6) 2018 ULTRASOUND OF RIGHT LOWER EXTREMITY VENOUS SYSTEM DUE TO LOWER LEG SWELLING AND PAIN. IMPRESSION: NORMAL RIGHT LOWER EXTREMITY VENOUS EVALUATION, NO INDICATION OF THROMBUS. REVISION OPERATIVE NOTES (B)(6) 2018 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, STIFFNESS AND DECREASED RANGE OF MOTION. UPON ENTERING THE JOINT, SYNOVITIS AND SCARRING WAS ENCOUNTERED. THE PATELLA WAS INDICATED TO BE SLIGHTLY OVERSIZED AND WAS MALTRACKING LATERALLY. THE FEMORAL COMPONENT WAS NOTED TO BE MALROTATED. THERE WERE NO ALLEGATIONS OF DEFICIENCY OF THE TIBIAL COMPONENT AND IT WAS INDICATED TO HAVE BEEN REVISED. FEMORAL, PATELLAR AND INSERT COMPONENTS WERE REVISED WITH ATTUNE REVISION IMPLANTS, INCLUDING DEPUY CEMENT X1. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT R

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9788251 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE OUTPATIENT SYNOVECTOMY. EVENT IREQUIRED THE USE OF ORAL MEDICATION. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9646650 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN WHEN STANDING FROM SEATED POSITION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS REMOTELY POSSIBLY RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: UNKNOWN, DOR: (B)(6) 2018, DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 9617653 ↗