ATTUNE 1517-10-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295055921), received between Nov 18, 2019 and Aug 7, 2026 — classified as 18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50178287 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE IN 2023; THERE WAS A PROXIMAL STRUT ALLOGRAFT PUT ON AT SOME POINT AFTER THE REVISION. THE PATIENT HAD PROXIMAL FEMOR PAIN, THE BONE SCAN SHOWED LOOSENING. A REVISION WAS PLANNED. KNOCKED THE SIZE 5 FEMOR OFF, THERE WAS NO LOOSENING OF OUR FEMORAL SLEEVES OR TIBIAL IMPLANTS. THE ALLOGRAFT WAS LOOSE, AND CABLES WERE LOOSE. THE SURGEON DECIDED TO RETRO FIT A NEW CRS REVISION SIZE 5 LEFT FEMORAL COMPONENT BACK INTO THE WELL INGROWN SLEEVE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23879995 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD A STRYKER PRIMARY KNEE, SHE FELL POST OP DAY 1 AND RUPTURED HER INCISION. SHE WAS REVISED THE NEXT DAY. SHE THEN DEVELOPED A MRSA INFECTION AND THE TISSUE ON THE FRONT OF HER KNEE DIED. THAT KNEE WAS EXPLANTED AND A STATIC SPACER WAS PUT IN PLACE AND PLASTICS HAD TO DO A GASTROC FLAP TO CLOSE THE WOUND. SHE CLEARED THE INFECTION AND AN ATTUNE REV WAS PREFORMED ON (B)(6) 2025 A COUPLE WEEKS AGO SHE BUMPED HER KNEE AND HAD A LESION ON HER KNEE WHICH BECAME INFECTED. WE WASHER HER OUT AND SWAPPED THE POLY TODAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Notching; Unspecified Infection

  MAUDE report 23843803 ↗
• InjuryNov 14, 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 INFECTION. SURGEON CONDUCTED A POLY/LINER SWAP. DOI-UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE-LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 23556436 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT (I&D) FOR HEMATOMA EVACUATION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Hematoma

  MAUDE report 22370870 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT UNSTABLE AND SURGEON DETERMINED PATIENT NEEDED A THICKER POLY INSERT. THERE WERE NO DELAYS OR COMPLAINTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22186612 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20051723 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND DOING A WASHOUT POLY EXCHANGE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18543176 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR LIGAMENT LAXITY. THE SURGEON REQUESTED A 5X14MM POLY. THE IMPLANT WAS CONTAMINATED DURING IMPLANTATION BY THE SURGEON. THE SURGEON CHOSE TO SOAK THE IMPLANT IN BETADINE AND MOVE FORWARD WITH IMPLANTATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16706342 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE. WASHOUT WAS PERFORMED WITH NEW POLY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16199620 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTED KNEE. SURGEON THROUGHLY WASHED OUT KNEE, AFTER REMOVING POLY. IT WAS REPLACED WITH A NEW POLY OF THE SAME SIZE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16102890 ↗
• InjuryApr 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A TKA SURGERY. ON UNKNOWN DATE, THE PATIENT WAS LYING WITH THE LOWER LEG HANGING OUT OF THE BED. WHEN THE PATIENT WOKE UP, THE PATIENT PUT HIS/HER FOOT ON THE FLOOR AND HAD A STRANGE FEELING. THE PATIENT VISITED THE HOSPITAL. WHEN AN X-RAY WAS CHECKED, IT WAS CONFIRMED THAT THE INSERT WAS ROTATING 90 DEGREES. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED, AND THE INSERT WAS REPLACED WITH A NEW ONE. WHEN A 12 MM INSERT TRIAL WAS FITTED, IT WAS NOT SO LOOSE, SO THE SURGEON INFERRED THAT THE ROTATION OF THE INSERT HAD BEEN GREATLY AFFECTED BY THE DROOPING OF THE LOWER LEG AT BEDTIME. CONSIDERING THE RISK OF DISLOCATION, THE SURGEON DECIDED TO USE A 16 MM INSERT AS A REPLACEMENT EVEN IF IT WAS A BIT TIGHT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 14249933 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOE: (B)(6) 2022. LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13471608 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POLY SWAP INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13288395 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12497146 ↗
• InjuryJun 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TROCHANTERIC BURSITIS, HIP AND KNEE PAIN AND CREPITUS EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: INJECTED MEDICATION (UNSPECIFIED) AND PHYSICAL THERAPY.

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

  MAUDE report 12073133 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATES SHE ORIGINALLY HAD BOTH KNEES REPLACED 20 YEARS AGO WITH PARTS OF AN UNKNOWN MANUFACTURER. SHE WAS REVISED TO DEPUY COMPONENTS DUE TO LOOSENING OF THE UNKNOWN MANUFACTURER'S PARTS. SHE HAD HER LEFT KNEE REVISED TO DEPUY COMPONENTS ON (B)(6) 2019 AND THE RIGHT REVISED TO DEPUY COMPONENTS ON (B)(6) 2019. BOTH KNEES HAVE HAD SIGNIFICANT PAIN AND FEELS UNSTABLE. THE LEFT HAD AN ARTHROSCOPY DONE ON (B)(6) 2020 WITH NO IMPROVEMENT. SHE HAS HAD INJECTIONS IN BOTH KNEES WITHOUT IMPROVEMENT IN PAIN. HER XRAYS ARE "CLEAR." SHE IS PLANNING TO VISIT HER SURGEON THIS WEEK TO DISCUSS ANOTHER REVISION DUE TO THE PAIN. THIS COMPLAINT WILL BE UPDATED TO THE LEFT PART/LOT AND ANOTHER COMPLAINT WILL BE CREATED TO CAPTURE THE RIGHT KNEE PART/LOT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11691416 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AFTER PERFORMING A LT KNEE REVISION SURGERY LAST (B)(6). THE SURGEON WANTS TO REMOVE ALL THE HARDWARE BECAUSE OF THE BONE LOSS WITH USING METAPHYSEAL SLEEVES, SO HE WANTED JUST TO DO A POLY EXCHANGE AND INCISION AND DRAINAGE. THE CRS INSERT WAS REMOVED, DID AN INCISION AND DRAINAGE USING STIMULAN BEADS AND IRRISEPT. THE SURGEON DECIDED TO USE A 8MM INSERT INSTEAD OF THE 10MM INSERT THAT WAS ORIGINALLY USED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Injury; No Code Available; Unspecified Infection

  MAUDE report 9337021 ↗