RESTORIS 180706-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486000943), received between Aug 7, 2017 and Feb 5, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. REP WAS NOT PRESENT FOR THE PROCEDURE, BUT WAS PROVIDED PICTURES OF A MAKO MCK TIBIAL ONLAY INSERT WHICH WAS WORN/ DELAMINATED ON TOP. PATIENT'S ENTIRE PKA CONSTRUCT WAS REVISED TO A TKA CONSTRUCT.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9670952 ↗
• InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD PAINFUL SWOLLEN KNEE. PATHOLOGY RESULTS CONCLUDED THAT THE KNEE WAS INFECTED. THE TIBIAL POLY INSERT WAS REMOVED, THE KNEE WAS THOROUGHLY IRRIGATED, AND A REPLACEMENT POLY LINER WAS INSERTED. TWO WEEKS AFTER PRIMARY PROCEDURE.

  Patient problems: Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 6772247 ↗

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