ATTUNE 1516-40-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295049678), received between Sep 17, 2019 and Oct 3, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2024 DUE DEVELOPMENT OF SOME KNEE PAIN. SURGEON PERFORMED AN ARTHROTOMY, WASHOUT, AND POLY SWAP. ORIGINAL IMPLANT DATE WAS (B)(6) 2020. THERE WAS NO SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: Pain

  MAUDE report 20360791 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY, NEEDED A THICKER POLY. DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 17259399 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. POLY WAS WASHOUT AND EXCHANGED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15744148 ↗
• InjuryDec 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED AND STATED THE FOLLOWING: THE PATIENT HAD BEEN SUFFERING FROM RIGHT KNEE PAIN FOR SEVERAL YEARS (NO INFORMATION PROVIDED REGARDING HOW MANY YEARS). HE/SHE WOULD HAVE UNDERGONE SEVERAL PROCEDURES RELATED TO THESE PAINS BEFORE 2014 (ARTHROSCOPIES AND MENISCECTOMIES) (NO INFORMATION PROVIDED REGARDING THESE PREVIOUS INTERVENTIONS). DUE TO PERSISTENT SEVERE PAIN, SEVERAL PROCEDURES WERE PERFORMED IN LATE 2014: IT WAS PERFORMED HYALURONIC ACID INJECTIONS ON (B)(6) 2014; AN ARTHROSCOPY WAS PERFORMED ON (B)(6) 2016. NO FOREIGN BODY WAS FOUND ON THIS OCCASION, EVEN THOUGH THE PREOPERATIVE MRI SUGGESTED IT ACCORDING TO THE SURGEON. A NEW HYALURONIC ACID INJECTION WAS THEN PERFORMED. IT IS IN THIS CONTEXT, AND BECAUSE OF PERSISTENT PAIN, THAT A TOTAL KNEE PROSTHESIS WAS PLACED DURING AN OPERATION ON (B)(6) 2021 AT THE (B)(6). AFTER THIS OPERATION, THE PATIENT SAID THAT HE/SHE FELT: SEVERE PAIN (THE LAWYER HAD NOTICED, HOWEVER, THAT THE PATIENT MENTIONED PAIN IN THE LEFT LEG EVEN THOUGH THE PROCEDURE INVOLVED THE RIGHT LEG) ; DIFFICULTIES TO SLEEP AND TO MOVE. IN ADDITION, THE SURGEON HAD NOTED THAT THE SURGICAL FOLLOW-UP WAS NOT CORRECT, STATING, "TODAY, THE P

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Loss of Range of Motion; Pain

  MAUDE report 13096276 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS INDICATE THE PATIENT UNDERWENT A SECOND REVISION OF THE LEFT KNEE SECONDARY TO PAIN AND SUSPECTED LOOSENING OF THE TIBIAL COMPONENT. INTRAOPERATIVELY, THE SURGEON NOTED FAIR AMOUNT OF SCAR TISSUE; THE FEMORAL AND PATELLAR COMPONENTS WAS WELL FIXED; AND CONFIRMED THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON REMOVED THE FEMORAL COMPONENT ALTHOUGH WELL-FIXED, DUE TO REVISING TO A NON-COMPATIBLE SYSTEM. THE PATELLA WAS RETAINED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. DOI: (B)(6) 2013, (TWO DEPUY CEMENT, TRAY, FEMUR). DOR: (B)(6) 2014, (TIBIAL INSERT). DOR: (B)(6) 2015, (LEFT KNEE).

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

  MAUDE report 9540663 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 27 AUGUST 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS, PATELLOFEMORAL CHONDROSIS, AND CONTRACTURE. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN EXCELLENT CONDITION. DEPUY COMPONENTS, AND TWO DEPUY CEMENTS WERE UTILIZED IN THE PROCEDURE. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY AND MCL REPAIR. THE SURGEON INDICATED HE WAS ABLE TO VERY EASILY ELEVATE THE TIBIAL TRAY AWAY FROM THE CEMENT. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ALL COMPETITOR COMPONENTS AND CEMENT WERE UTILIZED IN THE PROCEDURE. DOI: (B)(6) 2017. DOR: (B)(6) 2017, (LT KNEE).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9076097 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507