ATTUNE 1516-30-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295047667), received between Jan 3, 2019 and Mar 4, 2021 — classified as 6 injuries.

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

• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11413180 ↗
• InjuryApr 17, 2020Unintended Movement; Unintended Movement

  THE PATIENT RECEIVED A COMPLETE RIGHT KNEE REVISION TO TREAT RECURRENT INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED SIGNIFICANT SCAR TISSUE HAD FORMED ANTERIORLY TO THE INSERT WHICH CAUSED THE INSERT TO ROTATE LESS THAN 90 DEGREES POSTEROMEDIALLY AND NOT BE ABLE TO RETURN TO THE APPROPRIATE POSITION. THE SURGEON ALSO NOTES THE NATURAL PCL AND LCL WERE INSUFFICIENT AND SIGNIFICANTLY LOOSE. ALL COMPONENTS WERE REVISED TO A DEPUY HINGED REVISION SYSTEM INCLUDING A DOMED PATELLA UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. TIBIAL COMPONENTS: SIZE 2.5 MBT REVISION ROTATING PLATFORM TIBIAL BASEPLATE WITH A SIZE 29 MM MBT METAPHYSEAL POROUS SLEEVE AND A 75 MM LENGTH BY 16 MM DIAMETER UNIVERSAL FLUTED STEM WITH A 21 MM HEIGHT EXTRA-SMALL TIBIAL INSERT. FEMORAL COMPONENTS: SIZE EXTRA SMALL RIGHT ROTATING HINGE CEMENTED FEMORAL COMPONENT WITH A 34 MM FULLY POROUS UNIVERSAL FEMORAL SLEEVE AND A 75 MM LENGTH BY 16 MM DIAMETER UNIVERSAL FLUTED STEM. PATELLA: 35 MM DOMED PATELLA. PART/LOT STICKER SHEET WAS NOT PROVIDED IN THE OPERATIVE NOTES. DOI: (B)(6) 2019; DOI: (B)(6) 2019 (TIBIAL INSERT); DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9972561 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SECOND REVISION OF THE RIGHT KNEE ON (B)(6) 2019 SECONDARY TO PAIN, SWELLING AND SUSPECTED LOOSENING. INTRAOPERATIVELY, THE SURGEON NOTED THE PATELLAR COMPONENT WAS WELL-FIXED; THE POSTERIOR CRUCIATE LIGAMENT WAS LAX AND THERE WAS SIGNIFICANT PLACEMENT OF THE TIBIA IN RELATION TO THE FEMUR AND A 90-DEGREE FLEXED POSITION; AND THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9555317 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 ON THE PATIENT¿S LEFT KNEE JOINT VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 BY REPLACING THE TIBIAL INSERT (P/N: 151630410), WASHING OUT THE INFECTED AREA DUE TO INFECTION. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9175179 ↗
• InjurySep 13, 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 22 AUGUST 2019 FOR MDR REPORTABILITY. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO SEVERE INSTABILITY TO TOTAL KNEE ARTHROPLASTY. THE SURGEON INDICATED THE PATIENT¿S KNEE WAS AND NOT AMENABLE TO UTILIZING NORMAL REVISION COMPONENTS SO DECIDED TO UTILIZE A HINGE-TYPE PROTHESIS. THE SURGEON OFFERED NO ALLEGATIONS AGAINST THE FEMORAL, TIBIAL COMPONENTS, NOR THE PATELLA. THE SURGEON REPORTED NO SURGICAL COMPLICATIONS. DEPUY CEMENT AND CABLE WERE UTILIZED IN THE PROCEDURE. ALL OTHER COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS REVISION. DOI: (B)(6) 2016 - FEMORAL, TIBIAL TRAY, CEMENT 2X. DOI: (B)(6) 2016 - INSERT. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9035814 ↗
• InjuryJan 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL 1-DAY POST OP SEVERING MCL AND DISLOCATING IMPLANT. THE PATIENT WAS REVISED TO A CONSTRAINED FEMUR, NEW TIBIA AND INSERT.

  Patient problems: No Code Available

  MAUDE report 8212043 ↗