NA 214.885Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982154880), received between Mar 9, 2018 and Mar 9, 2018 — classified as 1 injury.

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 16, 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.

• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS AGAINST USER FACILITY REPORT MW5074624. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. IT WAS REPORTED THAT ON AN UNKNOWN DATE APPROXIMATELY THREE YEARS AGO, PATIENT WAS IMPLANTED WITH ONE (1) UNKNOWN TOTAL KNEE ARTHROPLASTY (TKA) CONSTRUCT (MANUFACTURER UNKNOWN). ON (B)(6) 2016, PATIENT UNDERWENT IMPLANT PROCEDURE TO TREAT LOSS STRESS FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE 4.5 MM (1) VARIABLE ANGLE (VA) CURVED CONDYLAR PLATE, EIGHT (8) 5.0 MM VA LOCKING SCREWS, ONE (1) 5.0 MM CANNULATED VA LOCKING SCREW, ONE (1) 4.5 MM CORTEX SCREW. SUBSEQUENTLY, ON AN UNKNOWN DATE, JUST FIFTY-ONE (51) DAYS AFTER THE PATIENT BEING RELEASED TO A FULL WEIGHT BEARING STATUS, THE PLATE BROKE AND THE PATIENT DEVELOPED A NONUNION AND THE BONE HAD RE FRACTURED. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. THE SURGEON WENT INTO SURGERY WITH THE PLAN TO NOT REMOVE THE IMPLANTS, BUT SUBSEQUENTLY, ENDED UP REMOVING ALL IMPLANTS. THE SURGEON CUT OUT THE TISSUE SURROUNDING THE PLATE AND THE PLATE WAS STILL STUCK. S

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7327944 ↗