RESTORIS 180613Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848486000769), received between Nov 20, 2020 and Apr 1, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryApr 1, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: BOOKED REVISION SURGERY. PATIENT WAS EXPERIENCING PAIN AND SHOWED SOME SIGNS OF TIBIAL LOOSENING ON SPEC CT SCAN, SURGEON MENTIONED HE BELIEVES THE PATIENT EXPERIENCED A STRESS FRACTURE AFTER PRIMARY SURGERY FOR THE POTENTIAL CAUSE. IMPLANT APPEARED WELL BONDED TO THE CEMENT MANTLE DURING EXPLANTATION.

  Patient problems: Inadequate Osseointegration; Pain; Periprosthetic fracture

  MAUDE report 24758374 ↗
• InjuryFeb 28, 2024Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  REVISED A RIGHT MEDIAL MCK UNI. REVISION WAS DUE TO TIBIAL LOOSENING/SUBSIDENCE. PATIENT WAS CONVERTED TO A TOTAL KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18796494 ↗
• InjuryNov 27, 2023Migration; Migration

  REVISED A RIGHT MEDIAL UNI DUE TO PER-ARTICULAR FRACTURE AND SUBSEQUENT TIBIAL BASEPLATE COLLAPSE. HE REVISED TO A TOTAL KNEE WITH MEDIAL TIBIAL AUGMENT, STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 18212119 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INSERTION OF MCK TIBIAL BASEPLATE, THE PROXIMAL MEDIAL SIDE OF THE TIBIA WAS FRACTURED. MANUAL TKA WAS PERFORMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 17997102 ↗
• InjuryMay 20, 2021Unstable; Unstable

  PKA WAS REVISED TO TKA DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11856017 ↗
• InjuryNov 20, 2020Loss of Osseointegration; Loss of Osseointegration

  A RESTORIS BASEPLATE WAS REVISED DUE TO LOOSENING. RIGHT MEDIAL UNICOMP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10874768 ↗

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