Restoration 6276-7-218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154058792), received between Nov 18, 2019 and Nov 18, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 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.

• InjuryNov 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REPORTED REVISION OF THE PATIENT'S HIP. AS REPORTED: "DR. WANTED TO REPLACE THE CONE BODY AND HEAD THE PATIENT HAD PREVIOUSLY HAD IMPLANTED ON (B)(6) 2014, AND CONVERT LINER TO MDM. WHEN TRYING TO SEPARATE THE CONE BODY FROM THE STEM, THE EXTRACTOR PIECE BROKE. WE HAD A BACKUP SET AT THE HOSPITAL, BUT THE SAME PIECE BROKE AGAIN, BUT HE WAS ABLE TO REMOVE THE CONE BODY FROM THE STEM." UPDATE: REASON FOR REVISION- LINER EXCHANGE, WITH HEAD, MDM, AND COME BODY EXCHANGE AS WELL DUE TO SUSPICION OF INFECTION. THIS SURGERY WAS A REVISION OF A REVISION. BODY SIDE: LEFT.

  Patient problems: Injury

  MAUDE report 9335218 ↗