RESTORIS 180602Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486000684), received between Nov 6, 2020 and Dec 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Malposition of Device; Migration; Malposition of Device; Migration

  THE PATIENT WHO HAD THE SURGERY OF MAKOMCK ON (B)(6) 2025 WILL HAVE A REVISION SURGERY ON (B)(6) 2025 DUE TO TIBIAL SUBSIDENCE.

  Patient problems: Insufficient Information

  MAUDE report 23851178 ↗
• InjuryJul 28, 2025Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 22635965 ↗
• InjuryJan 23, 2023Loss of Osseointegration; Loss of Osseointegration

  REVISED A RIGHT MAKO LATERAL UNI KNEE DUE TO TIBIAL LOOSENING. NO ALLEGATIONS MADE AGAINST THE IMPLANTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16226794 ↗
• InjuryJun 9, 2021Loss of Osseointegration; Loss of Osseointegration

  MAKO PKA WAS REVISED TO A TKA DUE TO TIBIAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11966490 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2016 THE PATIENT UNDERWENT A LEFT KNEE MEDIAL COMPARTMENT MAKOPLASTY AND DURING THAT PROCEDURE SIMPLEX HV BONE CEMENT WITH GENTAMICIN WAS UTILIZED TO CEMENT ALL COMPONENTS. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF HER TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10801270 ↗

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