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RESTORIS 186003-07Recalls & reported problems

Mako Surgical Corp. · Tapered Femoral Stem, Standard Neck, 12/14 Taper · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486008079), received between Sep 7, 2021 and Sep 7, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. THE PATIENT FELL AND FRACTURED HER FEMUR AND HUMERUS (SURGEON REPORTED POOR BONE QUALITY AS A CONTRIBUTING FACTOR). A MAKO STEM AND CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND ANOTHER FEMORAL HEAD. REP REPORTED THAT HE CAN PROVIDE PICTURES AND THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Bone Fracture(s)

    MAUDE report 12432269 ↗

Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices

All Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.