ATTUNE 1516-50-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295052494), received between Jun 19, 2018 and Nov 3, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AND POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23456052 ↗
• InjurySep 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT HAD REVISION SURGERY ON (B)(6) 2024 DUE TO INFECTION AND DISLOCATED DEVICE. THE PATIENT HAD A PREVIOUS IRRIGATION AND DEBRIDEMENT (I&D) AND POLYETHYLENE EXCHANGE OF THE LEFT KNEE ON (B)(6) 2024 BECAUSE OF A POSTOPERATIVE FALL AFTER A TOTAL KNEE ARTHROPLASTY (TKA). PATIENT WAS BROUGHT BACK ON (B)(6) 2024 FOR ANOTHER REVISION SURGERY TO WASH OUT THE LEFT KNEE JOINT AND EXCHANGE THE POLY AGAIN BECAUSE OF SUSPECTED INFECTION. PATIENT HAD ALSO DISLOCATED DEVICE SO A THICKER POLY WAS PUT IN. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 20250037 ↗
• MalfunctionSep 22, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE ATTUNE PS RP POLY WITH A LOT NUMBER OF 8869575 HAD AN EXPIRATION DATE OF 07/31/23 AND WAS IMPLANTED (B)(6 23. THE MANUFACTURE DATE WAS 08/09/18. THEY ARE LOOKING FOR CONFIRMATION THAT DPS HAS VALIDATED THE POLY AS BEING STERILE FOR 8 YEARS RATHER THAN 5. DOI: (B)(6) 2023, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17797967 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINT OF PAIN AND STIFFNESS. IMPLANT FIXATION WAS CHECKED- AND FOUND ALL WELL FIXED. POLY WAS DOWNSIZED 2MM FROM 16-14MM. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 17774712 ↗
• MalfunctionSep 7, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT COMPLEX PRIMARY KNEE RESULTED IN THE USE OF A SZ 5X15 PS RP ATTUNE INSERT. THE INSERT EXPIRATION DATE ON THE PACKAGE WAS 2023-07-31 WITH A 5 YEAR EXPIRATION FROM THE DATE OF MANUFACTURE. SUBSEQUENT TO THE MANUFACTURE DATE, DPS HAD VALIDATED THE STERILITY FROM 5 YEARS TO 8. THE PACKAGING WAS TO BE RE-LABELED WITH EXPIRATION DATES BASED ON THE 8 YEAR VALIDATION, BUT ONLY THIS INSERT NOR ANY OTHER INSERTS IN THE ACCOUNT HAD BEEN RELABELED. IT CAUSED CONCERN TO THE SURGEON, HOSPITAL, AND PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698542 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019: THE PATIENT UNDERWENT A SECOND REVISION TO THE LEFT KNEE SECONDARY TO SUSPECTED LOOSENING. NON-DEPUY CEMENT WAS USED. INTRAOPERATIVELY, THE SURGEON DEBRIDED SCAR AND NECROTIC TISSUE; REPORTED THE FEMUR WAS FIXED, HOWEVER EASILY TAPPED OFF WITH ALMOST ALL THE CEMENT AND NO BONE (CEMENT TO BONE INTERFACE); AND THE TIBIA WAS COMPLETELY DEBONDED, INDICATING LOOSENING AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. THE PATELLA WAS NOT REVISED. PMH: OSTEOARTHRITIS DOI: (B)(6) 2017; DOR: (B)(6) 2018 (POLY EXCHANGE); DOR: (B)(6) 2019 (SECOND REVISION; LEFT KNEE).

  Patient problems: Adhesion(s); Necrosis; No Code Available

  MAUDE report 9607211 ↗
• InjuryJun 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES SECOND I&D DUE TO INFECTION. ORIGINAL DOS WAS (B)(6) 2018, WITH THE FIRST I&D ON (B)(6) 2018. THE WOUND LOOKED CLEAN AND DRY FOR 10 DAYS AFTER THE FIRST I&D BUT THAN BEGAN DRAINING AGAIN THUS REQUIRING THE SECOND I&D WITH POLY EXCHANGE. THE JOINT CULTURED POSITIVE FOR STAPH-EPI. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7613356 ↗