RESTORIS 180514Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000639), received between Nov 16, 2021 and Sep 15, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K082172, K090763, K150307, K220930, K242831); they may or may not involve this specific model.

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.

• InjurySep 15, 2025Osseointegration Problem; Osseointegration Problem

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23056696 ↗
• InjuryOct 21, 2024Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING WAS REPORTED: "REVISED A RIGHT MEDIAL MCK UNI DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS."

  Patient problems: Inadequate Osseointegration

  MAUDE report 20495136 ↗
• InjuryFeb 21, 2022Loss of Osseointegration; Loss of Osseointegration

  AS PER PATIENT'S VOICEMAIL: PATIENT STATED HE HAD A TKA ON (B)(6) 2019. PATIENT STATED HE IS UNABLE TO WALK. UPDATE AS PER PATIENT: PATIENT STATED HE HAD A PKA ON (B)(6) 2019. PATIENT WAS TAKEN TO THE RECOVERY ROOM AND WAS TOLD HE HAD TO SEE A PT. HE ASKED THE NURSE TO USE THE BATHROOM BECAUSE HE COULDN'T GET OUT OF BED, HE WAS TOLD HE COULDN'T USE THE BATHROOM AS HE HAD TO DO PT FIRST. THE PATIENT ASKED FOR A PERCOCET FOR PAIN AND HE WAS TOLD HE COULDN'T GET ONE UNTIL AFTER PT. THE PHYSICAL THERAPIST ALSO TOLD HIM THAT HE COULDN'T USE THE RESTROOM UNTIL HE HAD PT. THE PHYSICAL THERAPIST ASSISTED HIM TO THE BATHROOM AFTER PT WAS DONE. WHILE THE PHYSICAL THERAPIST WAS ASSISTING, HE LET GO OF THE GATE BELT AND THE PATIENT FELL ON THE LEG THAT WAS OPERATED ON. THE PHYSICAL THERAPIST ASSISTED THE PATIENT TO THE BED AND TOLD THE PATIENT THAT HE WAS GOING TO REPORT THE FALL AND GET IN TOUCH WITH THE PHYSICIANS ASSISTANT. 1-2 HOURS LATER THE PHYSICIAN ASSISTANTS CAME TO CHECK ON THE PATIENT AND THE PATIENT TOLD THEM OF THE FALL. THE PHYSICIANS CHECKED THE WOUND AND THE PATIENT WAS DISCHARGED. THE PATIENT WAS TOLD IF HE EXPERIENCES ANY SYMPTOMS TO CALL THEM. PATIENT STATED THAT HI

  Patient problems: Fall; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 13573586 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISED TODAY WAS A PATELLOFEMORAL. PRIMARY AND CONVERSION IMPLANT SHEETS AS WELL AS PICTURES ARE PROVIDED HERE. REVISED DUE TO IMPROPER PATELLA TRACKING." SPOKE TO REP: REP CONFIRMED THERE ARE NO ALLEGATIONS AS TO INACCURATE CUTS MADE IN THE ORIGINAL MAKO PROCEDURE. REP ALSO CONFIRMED THAT THE REVISION WAS COMPLETED ROBOTICALLY, AND THAT NO FURTHER INFO WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Insufficient Information; Pain

  MAUDE report 12824606 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082172, K090763, K150307, K220930, K242831. One submission often covers many models, so check the product and lot details in each record.

• Z-1385-2023 · Mar 10, 2023 · Open, Classified
  stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
• Z-1386-2023 · Mar 10, 2023 · Open, Classified
  stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
• Z-2051-2018 · Jan 19, 2018 · Terminated
  Restoris MCK Onlay Insert Extractor.
• Z-1031-2016 · Jan 15, 2016 · Terminated
  Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
• Z-1132-2014 · Jan 9, 2014 · Terminated
  Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartme