ATTUNE 1516-30-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295047766), received between Oct 26, 2017 and Sep 26, 2024 — classified as 17 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (6 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 20311240 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON EXPLANTED THE IMPLANTS. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18960336 ↗
• InjuryFeb 7, 2024Adverse 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 WASHOUT FOR INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT

  Patient problems: Unspecified Infection

  MAUDE report 18659566 ↗
• InjuryDec 22, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE INSERT HAD SPUN OUT.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 18382779 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. WHAT IS THE EVENT DATE? I¿M NOT SURE OF THE EXACT DATE SORRY. PATIENT NOTES ONLY HAD THE YEAR. CAN YOU PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT PRODUCT? IF DEPUY, PLEASE PROVIDE THE PRODUCT CODE AND LOT NO. OF THE REPORTED PRODUCT. THIS SURGEON CURRENTLY USES DEPUY CEMENT, BUT I CAN¿T CONFIRM IF IT WAS USED AT THIS TIME. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? SORRY PATIENT NOTES ONLY SHOWED THE YEAR, NOT THE EXACT DATE. IMPLANT SCREENSHOTS WHICH I PROVIDED ON A PREVIOUS EMAIL WILL BE WITHIN A DAY OR SO OF (B)(6) 2018 WHAT WAS THE REASON FOR DEBRIDEMENT AND MUA IN 2019? WAS THERE ANY ADVERSE CONSEQUENCES/SYMPTOMS THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? REASON FOR MUA AND DEBRIDEMENT WAS DUE TO STIFFNESS AND PAIN. NO ADVERSE CONSEQUENCES NOTED.

  Patient problems: Insufficient Information; Muscular Rigidity; Pain

  MAUDE report 18021580 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS LOGGED TO CAPTURE THE PREVIOUS REVISION (2020) MENTIONED IN (B)(4). REVISION OF AN ATTUNE. RIGHT SIDE. PRIMARY WAS DONE IN [YEAR] IN [HOSPITAL] BY [SURGEON]. THEY HAD A DEBRIDEMENT AND MUA IN [YEAR]. REVISION OF THE FEMORAL COMPONENT AND INSERT IN [YEAR]. THIS WAS DONE IN [YEAR] BY [SURGEON]. I¿M NOT SURE WHAT THE PC NUMBER IS FOR THIS. THEY HAVE HAD ONGOING ISSUES SINCE FIRST SURGERY IN [YEAR]. THIS REVISION WAS DUE TO STIFFNESS AND PAIN. UNSURE OF THE LOT NUMBERS FOR THE FEMORAL COMPONENT AND TIBIAL COMPONENT REMOVED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , 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 BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INF

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18003781 ↗
• MalfunctionDec 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE DISCOLORATION ON THE BOX AND THE INNER PACKAGING OF THE PROTHESIS, SO HE CHOSE TO NOT USE THE AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022345 ↗
• MalfunctionDec 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE DISCOLORATION ON THE BOX AND THE INNER PACKAGING OF THE PROTHESIS, SO HE CHOSE TO NOT USE THE AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022344 ↗
• MalfunctionDec 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE DISCOLORATION ON THE BOX AND THE INNER PACKAGING OF THE PROTHESIS, SO HE CHOSE TO NOT USE THE AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022343 ↗
• MalfunctionDec 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE DISCOLORATION ON THE BOX AND THE INNER PACKAGING OF THE PROTHESIS, SO HE CHOSE TO NOT USE THE AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022339 ↗
• MalfunctionDec 21, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS NOT HAPPY WITH THE DISCOLORATION ON THE BOX AND THE INNER PACKAGING OF THE PROTHESIS, SO HE CHOSE TO NOT USE THE AFFECTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022338 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CLINICAL ADVERSE EVENT RECEIVED FOR FALL. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2021. LEFT KNEE. TREATMENT: POST PROCEDURE CAST TO MAINTAIN POSITION OF DISLOCATED (L) ELBOW & EPICONDYLE AVULSION FRACTURE, PHYSICAL THERAPY, OBSERVATION, AND MANIPULATION UNDER ANESTHESIA.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698721 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE MEDIAL HEMATOMA ON LEFT KNEE AT INCISION SITE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2017; (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION: SURGICAL ASPIRATION AND EVACUATION OF HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 14014761 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS TIGHT DUE TO SCAR TISSUE. DOI: (B)(6) 2020. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 12341788 ↗
• MalfunctionApr 7, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSERT WAS NEVER IMPLANTED IN A PATIENT. THE IMPLANT WAS NEVER OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631897 ↗
• InjuryDec 29, 2020Unintended Movement; Unintended Movement

  PATIENT SPUN OUT BEARING AND KNEE DISLOCATED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11089269 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN, SWELLING, AND INSTABILITY, WITH LOOSENING OF IMPLANT, RIGHT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION - ANALGESICS; DIAGNOSTIC INTERVENTIONS - CT, SCINTIGRAPHY (INVASIVE-RADIOISOTOPES INJECTED), ULTRASOUND; PHYSICAL THERAPY; REVISION SURGERY ON (B)(6) 2020 WITH EXPLANTATION OF STUDY KNEE. PATELLA WAS NOT RESURFACED DURING PRIMARY.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10679326 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ARTICULATING ATTUNE ANTIBIOTIC SPACER WAS PERFORMED AND PLACEMENT OF AN ATTUNE REVISION CONSTRUCT DUE TO INFECTION ABATEMENT. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10258325 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED TOTAL KNEE, INSERT REMOVED AND WASHED OUT AND NEW INSERT PLACED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9842918 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE REPLACEMENT. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF REVISION: (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9722618 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR COLLAPSE OF THE TIBIAL METAPHYSEAL BONE WITH INCREASED SLOPE OF THE TIBIAL COMPONENT AND POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2018; (LEFT KNEE).

  Patient problems: Failure of Implant

  MAUDE report 8842894 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8151373 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 6980254 ↗