ATTUNE 1516-50-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10603295052586), received between Apr 13, 2018 and Aug 10, 2026 — classified as 85 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Loss of or Failure to Bond

  It was reported that the patient has a loose tibial component. Doctor removed the tibial component and replaced with a revision tibia, stem and sleeve. Also replaced with the appropriate size poly for stability. No cement on the tibial component when it was explanted. It was stated that tibial component was loose. Loosening interface was marked as Cement to Implant.DOI: (b)(6) 2017.DOR: (b)(6) 2026.Affected side: Right.

  Patient problems: Joint Laxity

  MAUDE report 50193842 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED. SURGEON PERFORMED A PATELLAR TENDON REPAIR. REPLACED POLY WITH 14MM POLY TO HELP STABILIZE THE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24575969 ↗
• InjuryJul 10, 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. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22472173 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED JOINT. PATIENT HAD TO UNDERGO POLY SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22417490 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ARTIFICIAL KNEE JOINT REPLACEMENT TREATING THE RIGHT KNEE. AFTER THE SURGERY, INFECTION OCCURRED, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. IN THE REVISION SURGERY, THE INSERT IN QUESTION WAS REMOVED, DEBRIDEMENT WAS THOROUGHLY DONE, AND A NEW INSERT WAS INSERTED. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE INFECTION WAS A LATE INFECTION AND NOT ATTRIBUTABLE TO THE PROCEDURE OR PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22212915 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO POSTTRAUMATIC OSTEOARTHRITIS WITH MILD TO MODERATE VALGUS DEFORMITY AND MILD HYPEREXTENSION OF THE LEFT KNEE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR¿S BONE CEMENT. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT AND JOINT INSTABILITY. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS EASILY REMOVED AS IT HAD COMPLETELY DISLOCATED FROM THE CEMENT MANTLE. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH LITTLE BONE LOSS WITH HAND TOOLS AND OSTEOTOMES. THE SURGEON REPORTED THE PATELLA WAS INTACT AND WELL-FIXED AND WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2018 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 20655405 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINING OF STIFF KNEE. DOWN SIZED 7MM INSERT TO 5MM INSERT NO ADDITIONAL INFORMATION. NO DELAYS IN SURGERY. DOI- (B)(6) 2021. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 19709258 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY ATTUNE SIZE 6 RP PS 7MM INSERT WAS REMOVED AND REPLACED BY AN ATTUNE SIZE RP PS 10MM INSERT. THE PATIENT'S KNEE WAS MORE STABLE AS A RESULT OF THE THICKER INSERT. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19249817 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS ON (B)(6) 2023. PATIENT FALL CAUSED AN OPENING IN INCISION AND COMPROMISED SOFT, LIGAMENTS AND QUAD MUSCLE. AT THAT POINT PATIENT WAS WASHED OUT WITH A POLY EXCHANGE. NOW THE PATIENT IS WASHED OUT WITH A POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19152696 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND SEPTIC LOOSENING OF THE FEMUR AND TIBIAL COMPONENT AT THE BONE/CEMENT INTERFACE. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19106400 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO SURGICAL DELAY.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18807236 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. POLY EXCHANGE WAS PERFORMED. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(4) 2024; DOR: (B)(4) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18762525 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY SWAPPED, DUE TO LOOSENING. DOI: (B)(6) 2023, DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18314956 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BROUGHT IN FOR A WASHOUT DUE TO AN INFECTION. THE RP STABILIZE INSERT WAS EXPLANTED. THE KNEE WAS WASHOUT AND ANTIBIOTICS WERE GIVEN. A NEW SZ 6, 10MM RP STABILIZE INSERT WAS IMPLANT. THE PATIENT'S RIGHT KNEE. NO DELAY IN SURGERY. NO INJURY TO THE PATIENT. THE ORIGINAL DOS WAS (B)(6) 2021 AT A MEDICAL CENTER. DOE: (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 18084068 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18038064 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGICAL SITE WAS OOZING LIQUID AND WAS INFLAMED. THE INSERT WAS REMOVED AND WASHED OUT AND PUT IN A NEW INSERT. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Inflammation

  MAUDE report 17623377 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATTUNE RPPS CONSTRUCT ON (B)(6) 2023. SHE RECEIVED A PRESSFIT PS FEMUR, CEMENTED RP TIBIA, RPPS INSERT, 35 ANATOMIC PATELLA. UNFORTUNATELY, SHE EXPERIENCED A FALL 2 WEEKS AGO. IT WAS NOTED THAT SHE DEHISCED HER SURGICAL CLOSURE. IT IS SUSPECTED THIS IS HOW SHE BECAME INFECTED. UPON OPENING OF THE KNEE FOR THE WASHOUT ON MONDAY (B)(6) 2023, SHE DRAINED PUS AND WAS CONFIRMED FOR INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED TO TREAT THE CONFIRMED INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 17397967 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D POLY EXCHANGE FOR INSTABILITY. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17371735 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17333896 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. SURGEON EXPLANTED THE FEMUR, TRAY, INSERT AND PATELLA. THEN WASHED THE KNEE OUT AND IMPLANTED A NEW A POLY CURVED INSERT AND CR FEMUR WITH CEMENT TO ACT AS A SPACER UNTIL THE INFECTION WAS REMOVED. DOI: (B)(6) 2022. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17199789 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INCREASED PAIN AND SWELLING AFTER STUMBLE. POLY EXCHANGE PERFORMED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16888644 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. LINER WAS EXCHANGED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16629374 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE REPLACEMENT. IRRIGATION AND DEBRIDEMENT WAS PERFORMED WITH A LINER EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16131197 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. POLY WAS UPSIZED. THERE WAS NO LOOSENING OR SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15481525 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15310862 ↗