ATTUNE 1516-30-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295047650), received between Sep 24, 2019 and Sep 27, 2022 — classified as 5 injuries, 1 malfunction.

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

• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS EXPERIENCING INSTABILITY AND REQUIRED A POLY EXCHANGE FOR LEFT TOTAL KNEE REPLACEMENT. SURGEON ORIGINALLY DID THE PRIMARY REPLACEMENT ON (B)(6) 2022.

  Patient problems: Joint Laxity

  MAUDE report 15494062 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF INFECTED ATTUNE TKR AND DISTAL PERIPROSTHETIC PLATES AND SCREWS LEFT FEMUR. SEE (B)(4) FOR DETAILS OF FIRST REVISION. PATIENT HAS SINCE HAD CONFIRMED INFECTION IN LEFT KNEE. THIS PROCEDURE WAS TO REMOVE ALL COMPONENTS INCLUDING THE DISTAL PLATES AND SCREWS AND DEBRIDE, WASHOUT AND INSERT SPACER. CONFIRMED ON REMOVAL THAT THE DISTAL LATERAL PLATE AND SCREW WERE DEPUY SYNTHES PRODUCT. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13619598 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11027265 ↗
• MalfunctionMar 16, 2020Tear, 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 A SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA. DURING THE SURGERY, THE SURGEON FOUND THAT THE WHITE STERILIZED PACKAGE OF THE TIBIAL INSERT HAD TORN AND THE TIBIAL INSERT HAD COME OUT OF THE PACKAGE. THE SURGEON DID NOT USE IT BECAUSE HE JUDGED IT WAS UNCLEAN. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835511 ↗
• InjuryOct 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 03 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2013, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM AND DEPUY BONE CEMENT X 1. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY. THE SURGEON INDICATED THERE WAS VERY LITTLE FIXATION ON THE FEMORAL COMPONENT, AND WAS REVISED. THERE WERE NO COMPLAINTS REGARDING THE TIBIAL COMPONENT, AND IT WAS REVISED. THE SURGEON NOTED THE PATELLA WAS INTACT AND TRACKED WELL, AND NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2013; DOR: (B)(6) 2015; (RT KNEE).

  Patient problems: No Code Available

  MAUDE report 9244111 ↗
• InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT ON (B)(6) 2015 DUE TO INFECTION AND SWELLING. NO PRODUCTS WERE REVISED DURING THE PROCEDURE. THE SURGEON DECIDED ON (B)(6) 2015 TO GO BACK IN FOR ANOTHER IRRIGATION AND DEBRIDEMENT WITH A TIBIAL INSERT EXCHANGE DUE TO THE ONGOING INFECTION. THE PATIENT WAS ALSO TREATED WITH INTRAVENOUS ANTIBIOTICS. DOI: (B)(6) 2014. DOE: (B)(6) 2015, IRRIGATION AND DEBRIDEMENT (NO PRODUCTS REVISED). DOR: (B)(6) 2015, TIBIAL INSERT EXCHANGED RIGHT KNEE.

  Patient problems: No Code Available; Swelling; Unspecified Infection

  MAUDE report 9111558 ↗