ATTUNE 1516-50-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295052463), received between Aug 15, 2017 and Sep 3, 2026 — classified as 65 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a revision of primary Attune PS RP bearing occurred from a 10mm to an 18mm due to flexion and extension instability. All other implants were left insitu. The revision occurred on (b)(6) 2026. Original date of surgery unknown. Likely sometime between (b)(6) 2023.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 50590952 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to wound never healing. Put in static spacer.Affected side: Right knee.

  Patient problems: Impaired Healing

  MAUDE report 50116212 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHROTOMY TEAR- SWAPPED POLY THERE WAS NO ALLEGATION AGAINST IMPLANT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24815599 ↗
• InjuryJan 28, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT PRESENTED WITH A DISLOCATED KNEE. ONCE DOCTOR ASSESSED THE KNEE IN THE OR IT WAS DETERMINED THAT HE WANTED TO GO UP IN POLY SIZE SO THEY ORIGINAL POLY WAS REMOVED.

  Patient problems: Joint Dislocation

  MAUDE report 24200964 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A KNEE REVISION DUE TO INSTABILITY. DOI: ON (B)(6) 2016, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23084737 ↗
• InjuryJun 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 FALL. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 22175604 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL I&D WITH POLY SWAP. SURGEON FEELS BOTH KNEES ARE INFECTED AND WASHED OUT BOTH. THERE WAS NO WAY TO CONFIRM INFECTION. DOS OF RIGHT TKA WAS (B)(6) 2019 AND DOS OF LEFT TKA WAS (B)(6) 2020. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21925468 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL I&D WITH POLY SWAP. SURGEON FEELS BOTH KNEES ARE INFECTED AND WASHED OUT BOTH. THERE WAS NO WAY TO CONFIRM INFECTION. DOS OF RIGHT TKA WAS (B)(6) 2019 AND DOS OF LEFT TKA WAS (B)(6) 2020. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21925432 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WOUND DEHISCENCE DEBRIDEMENT WAS PERFORMED WITH POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 21917787 ↗
• InjuryApr 4, 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 CONTINUED INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21774321 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH STIFFNESS AND A BREAKDOWN OF HER SKIN JUST ABOVE HER PATELLA THAT WOULD NOT HEAL AFTER A REVISION TKA FOR INFECTION. WHILE LABS SHOW NO SIGN OF INFECTION SURGEON CHOSE TO CONFIRM OPERATIVELY AS SYMPTOMS ARE CONSISTENT WITH INFECTION. A FROZEN SECTION IS TAKEN OPERATIVELY AND NEGATIVE FOR INFECTION. SURGEON DID CHOSE TO EXCHANGE INSERT TO ONE THINNER INSERT AND REMOVED SIGNIFICANT SCARRING, LIKELY FROM THE PREVIOUS INFECTION. ROM IS FOUND TO BE MORE APPROPRIATE. ALL COMPONENTS ARE WELL FIXED AND WELL ALIGNED. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATIONS ARE MADE AGAINST ANY COMPONENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Adhesion(s); Impaired Healing; Muscular Rigidity

  MAUDE report 21305787 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WELL FIXED TKA, WHICH BECAME GLOBALLY UNSTABLE. THE INSTABILITY WAS NOT RELATED TO WEAR OF THE POLYETHYLENE, MALPOSITION OF COMPONENTS, OR UNDERSIZED COMPONENTS. THERE WAS NO EXCESSIVE RESECTION OF THE FEMUR OR TIBIA DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. A 5X10 WAS EXPLANTED AND 5X16 IMPLANTED. THE CEMENT MANUFACTURER WAS DEPUY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21158307 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD A PRIMARY KNEE DONE WITH ATTUNE PS RP. THE PATIENT HAD APPROXIMATELY A 25 DEGREE FLEXION CONTRACTURE AFTER THE TOTAL KNEE REPLACEMENT. THE PATIENT WAS BEING REVISED TO ADDRESS THAT CONTRACTURE. THE DOCTOR REMOVED THE SIZE 5 - 10MM PS RP INSERT AND IMPLANTED A SIZE 5 - 7MM PS RP INSERT TO REGAIN FULL EXTENSION. THE DOCTOR ALSO RESURFACED THE PATELLA WHICH WAS NOT DONE DURING THE PRIMARY PROCEDURE. HE IMPLANTED A SIZE 38MM DONE PATELLA. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 20938656 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SCAR EXCISION PROCEDURE AND POLY (SAME SIZE) WAS EXCHANGED AT THE SAME TIME, NO PROBLEMS WITH POLY/DEPUY PRODUCTS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 20630532 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20522206 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20521987 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 22 NOV 2018 DATE OF IMPLANT: (B)(6) 2018 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: : IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461531 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS UNSTABLE. NO FURTHER INFORMATION WAS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19973487 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CHIEF COMPLAINT WAS PAINFUL RIGHT TKA. THE PATIENT WAS INACTIVE FOR A LONG STRETCH AFTER A SEVERE BOUT OF COVID. THERE IS NO SIGN OF INFECTION OR IMPLANT LOOSENING. SURGEON DECIDED TO PERFORM SYNOVECTOMY, REMOVAL OF SCAR TISSUE, AND POSTERIOR CAPSULAR RELEASE. THERE WAS NO SIGN OF INFECTION OR IMPLANT LOOSENING. POLY WAS REMOVED AND REPLACED IN ORDER TO GAIN ACCESS TO THE POSTERIOR KNEE CAPSULE SURGICAL DELAY WAS UNKNOWN. DOI; (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain; Synovitis

  MAUDE report 19594589 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19312456 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. NO DELAY, NO PT CONSEQUENCES. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Adhesion(s)

  MAUDE report 18820353 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18284532 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED AS THE KNEE WAS GLOBALLY UNSTABLE SURGEON FOUND THE COMPONENTS TO BE WELL FIXED AND IN GOOD POSITION. INCREASED POLY THICKNESS FROM 10MM TO 14MM. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17940111 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT KNEE. A THINNER INSERT WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17846615 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT I&D WITH A POLY EXCHANGE ON THE RIGHT KNEE DUE TO A SUSPECTED INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(4) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17713902 ↗