NA 1294-56-127Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295026709), received between Jun 30, 2020 and Jun 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. UNIVERSAL STEM WAS FRACTURED AT THE JUNCTION WITH THE MBT REVISION TRAY. PATIENT STATUS/ OUTCOME / CONSEQUENCES, YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REVISION KNEE SURGERY WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IF YES, DESCRIBE REVISION KNEE SURGERY. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4): DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. (B)(4): DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. (B)(4): DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available

  MAUDE report 10215369 ↗