RESTORIS 180702-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486000820), received between Apr 10, 2019 and May 28, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2024Degraded; Naturally Worn; Degraded; Naturally Worn

  THE FOLLOWING WAS REPORTED "EXCESSIVE POLY WEAR, PATIENT 5 YEARS POST INDEX SURGERY. SWAPPED FOR A NEW POLY."

  Patient problems: Insufficient Information

  MAUDE report 19407729 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF A MAKO UNI RIGHT KNEE DUE TO INFECTION. HE REPLACED THE 2X8 WITH A 2X9 FOR BEST BALANCE. NO ALLEGATIONS AGAINST THE IMPLANTS MADE.

  Patient problems: Unspecified Infection

  MAUDE report 15552534 ↗
• MalfunctionApr 10, 2019Difficult to Insert; Difficult to Insert

  CUSTOMER REPORTED THAT THE POLY WOULD NOT STAY IN. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500657 ↗

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