ATTUNE 1517-10-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295055914), received between Jul 18, 2019 and Jul 27, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent I&D, poly swap.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left Knee.

  Patient problems: Insufficient Information

  MAUDE report 50012090 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT TKA SURGERY FOR SEVERE VALGUS OA ON THE RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2026, THE SURGEON REPORTED THAT A DISLOCATION HAD OCCURRED AND THAT A REVISION SURGERY FOR INSERT EXCHANGE IS SCHEDULED FOR (B)(6) 2026. AT PRESENT, THERE ARE NO IDENTIFIED ISSUES WITH THE FEMORAL OR TIBIAL COMPONENTS, AND NO REVISION IS PLANNED FOR THESE COMPONENTS. THE DISLOCATION IS PRESENT, AND THE INSERT THICKNESS IS PLANNED TO BE INCREASED. THE CURRENT INSERT THICKNESS IS 8 MM, AND IT IS PLANNED TO BE REPLACED WITH A 10 MM OR 12 MM INSERT. THE SURGEON NOTED THAT A CRS INSERT WAS USED DUE TO THE SEVERE VALGUS DEFORMITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 25306307 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR PAIN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 24884469 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24747461 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PAINFUL TOTAL KNEE ARTHROPLASTY (TKA), WHERE THE PATIENT REQUIRED AN INCREASE IN POLY SIZE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 23976711 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REPORTED FOR FEMORAL LOOSENING. RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20320964 ↗
• InjuryAug 9, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR OA WITH THE IMPLANT IN QUESTION. AFTER THE SURGERY, THE PATIENT WHO FELT DISCOMFORT IN THE MOVEMENT OF THE KNEE, VISITED A DOCTOR AND WAS FOUND TO HAVE A SPINOUT. ON (B)(6) 2023, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE INSERT. DOI: (B)(6) 2021. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 17486608 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT TKA WAS INFECTED. ATTUNE REVISION FOR REVISION OF UNI CONDYLAR, REMOVED = SPACER, IMPLANTATS SONICATION. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17181614 ↗
• InjuryFeb 4, 2023Adverse 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) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16301914 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO THIGH PAIN. NO EVIDENCE OF INFECTION OR LOOSENING. SURGEON SUSPECTED THE PAIN MAY BE BEING GENERATED FROM A LARGE FEMORAL PRESS FIT STEM. AFTER DISCUSSIONS WITH THE PATIENT, THE DECISION WAS MADE TO DO A FEMORAL ONLY REVISION - PLAN A BEING TO REVISE THE FEMORAL SLEEVE TO A LARGER SIZE AND REDUCE THE FEMORAL STEM DIAMETER. PLAN B WOULD BE EITHER AN S-ROM HINGE OR LPS DISTAL FEMORAL REPLACEMENT DEPENDING ON BONE QUALITY FOLLOWING REMOVAL OF THE CURRENT ATTUNE REVISION FEMORAL COMPONENTS. THE REMOVAL PROCESS WAS NOT SIMPLE AS THE INITIAL COMPONENTS WERE WELL FIXED, AND AS A RESULT THERE WAS A COMPLETE FRACTURE OF THE LATERAL DISTAL FEMORAL CONDYLE AS WELL AS SIGNIFICANT METAPHYSEAL BONE LOSS OF THE DISTAL FEMUR WHILST ATTEMPTING TO REMOVE THE WELL FIXED SLEEVE AND STEM. PALACOS BONE CEMENT WAS USED IN ALL PROCEDURES. PLAN B WAS ACTIONED AND A LPS DISTAL FEMORAL REPLACEMENT WAS PERFORMED.

  Patient problems: Discomfort; Pain

  MAUDE report 14886483 ↗
• InjuryJun 17, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 14731181 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14714323 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LLI RUPTURE POST OP . (B)(6) 2022 FIRST IMPLANTATION ON A TIBIA FRACTURE . REVISION (B)(6) 2022. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 14021435 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THE FOLLOWING: 1. WAS SURGERY TIME EXTENDED? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. 2. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT SIDE. 3. ON 01-MAR-2022 WERE ANY DEPUY PRODUCTS REVISED/EXPLANTED? NO. 4. HOW DID THE SURGEON RESOLVE THE LIMITED FLEXION ISSUE? AFTER INITIAL EXPOSURE, SCAR TISSUE WAS EXTENSIVELY CLEARED AND STRETCHING OF THE REMAINING SOFT TISSUES RESULTED IN AN OUTCOME ROM AND RESTING STATE THE SURGEON WAS HAPPY WITH. 5. USAGE FOR THE PATIENT'S REVISION PROCEDURE 3 YEARS AGO HAS BEEN IDENTIFIED IN THE KIT DIARY (SEE BELOW). TO YOUR KNOWLEDGE WERE BOTH SIDES REVISED ON (B)(6) 2019? NO, ONLY ONE SIDE HAS A REVISION, THE OTHER SIDE HAS MORE RECENTLY HAD A PRIMARY DONE USING ZIMMER (MID-LATE 2021). I CANNOT SPEAK TO THE DOUBLE UP WITH STEMS AND SLEEVES.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13770319 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LEFT TOTAL KNEE REPLACEMENT. REMOVAL OF ATTUNE REVISION IMPLANTS, (TIBIAL SLEEVE WAS NOT REMOVED), DUE TO STIFFNESS, INSTABILITY. THERE WAS NO EXTENDED SURGICAL TIME. SURGEON STATED THE FEMORAL IMPLANT WAS OVERSIZED. NO DEFICIENCY WITH THE PRODUCT.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 12277388 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT IN FLEXION AND EXTENSION. SURGEON REVISED INSERT FROM 8 MM TO 6 MM. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11711271 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION KNEE DUE TO INFECTION. PRIMARY SURGEON PROF. (B)(6). FEMALE PATIENT ID: (B)(6). IMPLANTS STILL IMPLANTED: 1 X 151820038 ATTUNE MEDIAL DOME PAT 38MM - LOT 9268987. 1 X 151314060 ATUNE PRESSFIT STR STEM14X60MM - LOT J1946P. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9847674 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BOUGHT BACK FOR IRRIGATION AND DEBRIDEMENT OF WOUND. SURGEON REPLACED ATTUNE REVISION RP LINER AND PLACED ANTIBIOTIC BEADS. IMPLANTS WERE WELL FIXED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9225818 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8803097 ↗