CONSERVE® 38AC4800Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M68438AC48001), received between Mar 17, 2020 and Jul 13, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Disintegration” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY THE PATIENT IS EXPERIENCING MOM COMPLICATIONS. SUBJECT WAS SEEN (B)(6) 2018 FOR STUDY VISIT. THE LEFT THA IS ASYMPTOMATIC. THE METAL ION LABS WERE ELEVATED, THE MARS MRI SHOWED POSSIBLE ALTR. THE PI WOULD LIKE TO FOLLOW UP AT VISIT 2 WITH REPEAT LABS AND MRI. THE NECK AND STEM ARE NOT MICROPORT PRODUCTS. (B)(4) ADDITIONAL INFORMATION: ALLEGEDLY PATIENT WAS SEEN FOR STUDY VISIT 2 ON (B)(6) 2019 AND PI IS RECOMMENDING REVISION SURGERY DUE TO ADVERSE LOCAL TISSUE REACTION. (B)(4) ADDITIONAL INFORMATION ON 02/20/2020: REVISION SURGERY CONFIRMED ON (B)(6) 2020 DUE TO ADVERSE LOCAL TISSUE REACTION , THE LARGE FEMORAL STEM AND NECK SLEEVE WERE REMOVE.

  Patient problems: Reaction

  MAUDE report 10264760 ↗
• InjuryMar 17, 2020Material Disintegration; Unstable; Material Disintegration; Unstable

  ALLEGEDLY, PATIENT HAD HIGH COCR LEVELS, THE CUP WAS REMOVED WITHOUT CUP CUTTERS. PATIENT IS OR WAS A SMOKER.

  Patient problems: No Code Available

  MAUDE report 9844802 ↗