RESTORIS 180614Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848486000776), received between Aug 31, 2018 and Jan 3, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Fracture; Fracture

  HAD A REVISION OF A POSSIBLE LOOSE OR BROKEN MAKO UNI BASEPLATE AFTER THE PATIENT COMPLAINED OF PAIN AFTER FALLING. ONCE THE SURGEON GOT INTO THE JOINT HE CONFIRMED THE METAL BASEPLATE WAS BROKEN IN HALF.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 18434873 ↗
• InjuryNov 4, 2023Unintended Movement; Migration; Unintended Movement; Migration

  PLANNED REVISION SURGERY. PATIENT PRESENTED AT 2 YEAR FOLLOW UP APPOINTMENT WITH X-RAY SHOWING THE UNI TIBIAL BASEPLATE HAD SUBSIDED. DURING THE REVISION SURGERY FROM A MEDIAL UNI TO TOTAL KNEE THE TIBIAL AND FEMORAL COMPONENTS APPEARED TO BE WE WELL FIXATED TO BONE. THEY WERE REMOVED WITH MINIMAL OR NO BONE LOSS AND A PRIMARY TRIATHLON KNEE WAS IMPLANTED.

  Patient problems: Insufficient Information; Subluxation

  MAUDE report 18070532 ↗
• InjuryAug 25, 2023Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "REVISED A RIGHT MEDIAL UNI DUE TO (CEMENTED) TIBIAL LOOSENING." PATIENT WAS CONVERTED FROM A PKA 3.0 TO A TKA. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE ROBOT OR CUTS IN LIGHT OF THE TIBIAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17624234 ↗
• InjuryMar 7, 2023Loss of Osseointegration; Loss of Osseointegration

  REVISION OF MAKO PKA TO TKA. TIBIAL LOOSENING NOTED AS REASON FOR REVISION ON REGISTRY FORM. INITIAL PKA PERFORMED (B)(6) 2021.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16498870 ↗
• 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 HIS WIFE WA

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

  MAUDE report 13573588 ↗
• InjuryNov 7, 2021Fracture; Fracture

  DR. PERFORMED A REVISION OF A MAKO PARTIAL KNEE DONE IN 2018 BY ONE OF HIS PARTNERS. ACCORDING TO DR. THE PATIENT HAD BEEN EXPERIENCING PERSISTENT PAIN AND AN ADVANCEMENT OF ARTHRITIS IN THE LATERAL AND PATELLOFEMORAL COMPARTMENTS. PREOPERATIVE CT IMAGES SUGGESTED THAT THE TIBIAL BASEPLATE MAY HAVE FAILED. COMPONENT REMOVAL CONFIRMED THAT THE TIBIAL BASEPLATE METAL HAD BROKEN. THE PARTIAL KNEE WAS SUCCESSFULLY CONVERTED TO A CEMENTED TRIATHLON TKA.

  Patient problems: Ambulation or Postural Difficulties; Arthritis; Pain

  MAUDE report 12758362 ↗
• InjuryMar 11, 2020Migration; Migration

  A RESTORIS PARTIAL KNEE WAS REVISED DUE TO THE TIBIA COMPONENT SUBSIDING. THE SURGEON DECIDED TO REPLACE THE TIBIAL COMPONENT WITH ANOTHER RESTORIS, BUT ONE SIZE BIGGER. THE POLY WAS ALSO CHANGED FROM 9 TO 10 MM.THE PRIMARY OPERATION WAS DONE ON (B)(6)2019 . THE REVISION WAS DONE ON (B)(6)2020 .

  Patient problems: Injury

  MAUDE report 9819395 ↗
• InjuryDec 26, 2018Osseointegration Problem; Osseointegration Problem

  A REVISION OF A TIBIAL COMPONENT FOR LOOSENING WAS REPORTED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8197284 ↗
• InjuryAug 31, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  MAKO UNI PKA PERFORMED (B)(6) 2018. REVISED TO TKA FOR TIBIAL LOOSENING (B)(6) 2018. REVISED TO TRIATHLON TKA. PAIN AND X-RAY CHANGES NOTED AT FOLLOW UP APPOINTMENT, REVISION CASE BOOKED.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7838785 ↗

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-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-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-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