RESTORIS, RIO 207084Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486022204), received between Nov 16, 2018 and Oct 25, 2019 — classified as 4 malfunctions.

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

• MalfunctionOct 25, 2019Degraded; Material Fragmentation; Degraded; Material Fragmentation

  EVENT DESCRIPTION :THE ISSUE WAS THAT THE REAMER AND THE MICS ATTACHMENT STRIPPED THE METAL ON THE BACK OF THE STRAIGHT REAMER. CASE TYPE: THA SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9237971 ↗
• MalfunctionAug 3, 2019Break; Fracture; Break; Fracture

  SURGEON JUST STARTED REAMING THE ACETABULUM WITH STRAIGHT REAMER HANDLE. PROXIMAL END TIP OF REAMER HANDLE SNAPPED OFF LEAVING APPROX 1CM METAL PIECE ON THE GROUND. CASE CONTINUED WITH SECOND REAMER HANDLE. 30 SECOND DELAY. UPDATE: "NO DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT AND NO COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED." NO. SURGICAL DELAY: 30 SECONDS. CASE TYPE: THA.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8858297 ↗
• MalfunctionJun 21, 2019Contamination /Decontamination Problem; Non Reproducible Results; Contamination /Decontamination Problem; Non Reproducible Results

  IMPACTOR IS CONSISTENTLY CONTAINING BIO BURDEN AFTER STERILIZATION. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8723993 ↗
• MalfunctionNov 16, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  THE SPRING ON THE REAMER IS BROKEN.THIS WAS A THA PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077432 ↗