NA 5460-16-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295174356), received between Sep 6, 2017 and Jan 5, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Disassembly” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PREVIOUSLY REVISED KNEE WAS REVISED A SECOND TIME DUE TO PAIN AND INSTABILITY. THE PATIENT'S ATTUNE REVISION KNEE COMPONENTS WERE REMOVED AND REPLACED BY AN S-ROM NOILES HINGED FEMUR, AN LPS HINGED RP INSERT, AND A SIGMA REVISION MBT TIBIAL TRAY. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIOR REVISION PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENT. THE PRODUCT CODES AND LOT NUMBERS FOR THE CEMENT IS NOT AVAILABLE, SINCE THE CEMENT USED WAS HOSPITAL INVENTORY ORDERED DIRECTLY FROM DEPUY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13170669 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD REPORTS PATIENT'S FOLLOW UP NOTES FOR HER ENCOUNTER WITH PHYSICIAN ON (B)(6) 2018 AS REPORTS OF ONGOING PAIN (WHEN ATTEMPTING TO STAND) POST REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY (DOR (B)(6) 2017). RADIOGRAPHIC IMAGES GIVE NO INDICATION OF IMPLANT DEFECTS. PATIENT HAD SEEN A PAIN SPECIALIST AND RECEIVED A RADIOFREQUENCY ABLATION WITHOUT BENEFITS. PHYSICAN'S DECISION WAS FOR PATIENT TO CONTINUE THERAPY AND FURTHER FOLLOW UPS WITH X-RAYS.

  Patient problems: No Code Available; Pain

  MAUDE report 9511499 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECONDARY TO FOLLOW-UP INFORMATION RECEIVED, THIS PRODUCT IS NO LONGER CONSIDERED A SERIOUS INJURY AT THIS TIME.

  Patient problems: Not Applicable; Pain

  MAUDE report 9363243 ↗
• InjurySep 6, 2017Disassembly; Malposition of Device; Disassembly; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM. LOOSENING OCCURED AT IMPLANT TO CEMENT INTERFACE. DEPUY CEMENT WAS USED.

  Patient problems: No Information

  MAUDE report 6846244 ↗