ATTUNE 1516-50-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295052159), received between Aug 28, 2018 and Jun 27, 2025 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT RECEIVED A PRESS FIT KNEE. DOCTOR REPORTED THAT IT WAS LOOSE, SO SURGEON REVISED IT. THERE WAS LOOSENING OF FEMUR AT NON CEMENTED INTERFACE. UNKNOWN CEMENT WAS USED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22344869 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. THE PATIENT HAD BEEN IN PAIN FOR A FEW MONTHS. DOI: (B)(6) 2017, DOR: (B)(6) 2023, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16541859 ↗
• InjuryFeb 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR KNEE OA WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. 4 DAYS AFTER THE SURGERY, THE PATIENT HAS DISLOCATION DURING HOSPITALIZATION ON (B)(6) 2023. A REVISION SURGERY WAS DONE (B)(6) 2023. ACCORDING TO THE SURGEON, IT IS POSSIBLE THAT THE LIGAMENT WAS DAMAGED DURING THE SURGERY OR THAT THE GAP WAS NOT CREATED PROPERLY, BUT THE UNDERLYING CAUSE OF THE DISLOCATION IS UNKNOWN. HE PLANS TO CHECK THE STATUS WHEN REPLACING NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED AREA: UNKNOWN KNEE.

  Patient problems: Bone Fracture(s); Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16434978 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON REMOVED ALL COMPONENTS AND REVISED TO AN ANTIBIOTIC SPACER BECAUSE THE KNEE WAS INFECTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16266395 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH KNEE INFECTION. DEPUY BONE CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16156775 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFF KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 15969412 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT COMPLAINED OF INSTABILITY. THEN, THE REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE. THE INSERT REPLACED FROM 6MM TO 14MM. THE SURGEON COMMENTED THAT THE OBSERVATION DURING THE PRIMARY SURGERY WAS GOOD, BUT THAT IT MAY HAVE LOOSENED AFTER THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 15886049 ↗
• InjuryOct 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND DIAGNOSTIC INTERVENTION (SCINTIGRAPHY AND X-RAYS).

  Patient problems: Pain

  MAUDE report 15612695 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTIONS (SCINTIGRAPHY AND X-RAYS) AND MANIPULATION UNDER ANESTHESIA.

  Patient problems: Pain

  MAUDE report 15502247 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CHEST X-RAY RESULT RIGHT LOWER ZONE MEDICALLY. TREAT AS A RESPIRATORY TRACT INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: COMMENCED ON IV ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10567785 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE AND PAIN. DOI: (B)(6) 2018 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10414315 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: RECEIVED 1 UNIT PACKED RED BLOOD CELLS WHILE IN THE HOSPITAL; RESOLVED (B)(6) 2019.

  Patient problems: Anemia; No Code Available

  MAUDE report 10288555 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TIGHTNESS IN BOTH FLEXION AND EXTENSION. THE PRIMARY ATTUNE FEMORAL COMPONENT WAS REMOVED, SO THAT A POSTERIOR CAPSULE RELEASE COULD BE PERFORMED. HER MEDIAL COLLATERAL LIGAMENT WAS ALSO RELEASED OR LENGTHEN SLIGHTLY. A REPLACEMENT ATTUNE PS FEMUR OF THE SAME SIZE AND A REPLACEMENT ATTUNE RP PS TIBIAL INSERT WAS IMPLANTED. THE PRIMARY RP TIBIAL BASE (TRAY) WAS NOT REVISED. THERE WAS NO SUGGESTION BY ANYONE THAT THERE WAS OR MAY BE DEFICIENCIES WITH THE PRODUCTS. NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10257356 ↗
• InjuryMay 13, 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 8603345 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8603116 ↗
• InjuryAug 28, 2018Fitting Problem; Fitting Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY DUE TO POLY SIZE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7823601 ↗