ATTUNE 1516-50-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295052593), received between Mar 21, 2018 and Sep 29, 2026 — classified as 66 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient has renal failure and was in poor general health. Knee has been infected for a while. Doctor replaced these components with a new femur and all poly tibia - with antibiotic cement, as a spacer.DOI: (b)(6) 2020.DOR: Unknown.Affected Side: Right knee.

  Patient problems: Unspecified Infection

  MAUDE report 50935142 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Poly was swapped for possible infection.DOI: (b)(6) 2026.DOR: (b)(6) 2026. Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50305340 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to ligamentous instability and loosening of the tibia at the cement to implant interface. DePuy cement was used.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50131461 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN AND BROKEN THEIR DISTAL FEMUR. ANOTHER SURGEON HAD PLACED AN X-FIX ON THE PATIENT. PATIENT CAME BACK TO SEE DOCTOR AND THE DOCTOR SAID THAT PATIENT'S TOTAL KNEE WAS SHOWING SIGNS OF INFECTION FROM THE PINS ON THE X-FIX. THE DOCTOR CHOOSE TO REMOVE THE TOTAL KNEE AND REPLACE IT WITH A CEMENT SPACER. NOTHING WAS MENTIONED ABOUT ISSUES WITH THE SYNTHES IMPLANTS. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 25480994 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT FALL, AFTER WHICH A WASHOUT AND POLYETHYLENE INSERT EXCHANGE WERE PERFORMED. THERE WAS NO REPORTED MALFUNCTION OF THE IMPLANT ITSELF. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 24422294 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED BY DOCTOR FOR INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22905213 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22796378 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED KNEE AND DR DECIDE TO REMOVE THE IMPLANT, WASH THE KNEE OUT AND REINSERT A NEW IMPLANT. THE PATIENT T WAS NOT AFFECTED DURING THIS EVENT. THERE WAS NO ISSUE WITH THE EXISTING IMPLANT, IT WAS JUST REMOVED AS A PRECAUTIONARY EFFORT. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22542404 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 20630043 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: I SEE ON THE EMAIL YOU HAVE INCLUDED WHAT WE WASTED A 14X30MM CEMENTED STEM. THAT IS INCORRECT. IT WAS A SIZE 4 RP TIBIAL TRAY. AND THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS THE PATIENTS MCL TORE AFTER INITIAL IMPLANTATION WHICH IS WHY WE TOOK EVERYTHING OUT AND PUT IN REVISION PARTS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20406315 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19960299 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE DEVICE WAS EXPLANTED AND SPACER WAS PLACED DUE TO SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19817064 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS SWAPPED AND SCAR TISSUE EXCISION WAS DONE. PATIENT COMPLAINING OF LACK OF FLEXION. 8MM POLY REMOVED, 8MM REIMPLANTED. ALL IMPLANTS WELL FIXED. THERE WAS NO SIGN OF INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 19222594 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION/EXTENSION MISMATCH. PATIENT IS TIGHT IN EXTENSION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 18049698 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. INSERT WAS EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17808877 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IRRIGATION AND DEBRIDEMENT WITH CONSTRAINED COMPONENTS AS A TEMPORARY SPACER. DOI: (B)(6) 2018 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17683495 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP DUE TO MID FLEXION INSTABILITY. INCREASED POLY SIZE FROM 8MM TO 12MM. PATIENT ACHIEVED STABILITY W THICKER POLY. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17118442 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17040395 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY WAS REVISED FOR POOR MOTION. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16796226 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FELL A WEEK AND A HALF AFTER THEIR INITIAL SURGERY AND THE SURGEON WENT IN AND CHANGED THE POLY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall

  MAUDE report 16378065 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. THERE WAS NO LOOSENING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16194669 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16193992 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16113642 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO STIFF RIGHT TOTAL KNEE. IT WAS DOWNSIZED TO 5MM POLY. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 16059807 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15846602 ↗