RESTORIS 180605Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848486000714), received between Jul 29, 2019 and Jul 18, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS CONVERTED FROM AN MCK PKA TO A COMPETITOR TKA. MPS REPORTED ORIGINAL SUSPICION WAS TIBIAL SUBSIDENCE. MPS WAS NOT PRESENT FOR THE REVISION, BUT AFTER THE CASE WAS PROVIDED WITH THE EXPLANTS AND THE BASEPLATE WAS BROKEN IN HALF.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17347673 ↗
• InjuryNov 10, 2022Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  REVISED A MAKO LEFT MEDIAL UNI DUE TO TIBIAL BASEPLATE LOOSENING. NO OTHER ALLEGATIONS MADE AGAINST THE IMPLANTS. HE REVISED TO A PRIMARY CEMENTLESS TOTAL KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15771053 ↗
• InjuryJan 10, 2022Fracture; Fracture

  TIBIA BASEPLATE BROKE IN HALF. EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13202872 ↗
• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  RESTORIS IMPLANTS WERE REVISED DUE TO FEMORAL AND TIBIAL IMPLANT LOOSENING. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017 AT (B)(6). REVISION WAS DONE ON (B)(6) 2020 AT THE SAME HOSPITAL AND BY THE SAME SURGEON. NEW IMPLANTS OF THE SAME TYPE WERE IMPLANTED. FEMORAL AND TIBIAL COMPONENT OF THE SAME SIZE WERE USED, THE INSERT THICKNESS WAS CHANGED FROM 9 MM TO 12 MM. THE REVISION WAS CARRIED OUT SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10296320 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE IMPLANTS FOR PATIENT 1 OF 3. (B)(6) YO MALE, SURGERY (B)(6) 2019. AS REPORTED BY SURGEON: ATTACHED ARE XRAYS OF THREE PATIENTS I PREVIOUSLY DISCUSSED. ALL HAVE CONCERNING RADIOLUCENCIES UNDERNEATH THE TIBIAL BASEPLATE THAT APPEARED SEVERAL MONTHS POST OP. THUS FAR, NONE HAVE REQUIRED REVISION BUT ALL HAVE SOME DEGREE OF PAIN (MOSTLY MEDIAL). AGAIN I NEVER SAW THIS PRIOR THE MICS TRANSITION. LET ME KNOW YOUR THOUGHTS AND IF ANY OTHER SURGEONS HAVE SEEN THIS ISSUE. MORE RECENTLY, I HAVE BEEN USING A 2MM DRILL TO PERFORATE THE SCLEROTIC TIBIAL SURFACE TO PROMOTE BETTER CEMENT INTERDIGITATION AND MY RESULTS SEEM TO BE MUCH BETTER. CASE TYPE: PKA 3.0.

  Patient problems: Pain

  MAUDE report 9794144 ↗
• InjuryJul 29, 2019Osseointegration Problem; Osseointegration Problem

  MAKO UNI REVISED FOR ASEPTIC LOOSENING OF TIBIAL COMPONENT. REVISED TO TKA.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8836503 ↗

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