RESTORIS 180604Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00848486000707), received between Dec 11, 2020 and Sep 12, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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.

• InjurySep 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT MEDIAL UNI KNEE WAS REVISED DUE TO THE TIBIAL BASEPLATE BREAKING IN HALF (NO CAUSE OR CONTRIBUTOR TO THE BREAKAGE WAS REPORTED TO THE REP). THE INSERT BECAME DAMAGED/ WARPED AS A RESULT. THE PATIENT WAS CONVERTED TO A TKA WITH STEM AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 23036275 ↗
• InjuryMar 4, 2024Fracture; Fracture

  MAKO UNI TIBIA BASEPLATE WAS BROKE IN HALF. POLY WAS STILL INTACT. THE UNI WAS REVISED INTO A TKA. NOTICED VIA X-RAY. ORIGINAL SURGERY WAS AROUND 7-8 YEARS AGO. UPDATE 08/FEBRUARY/2024 WG: LEFT MEDIAL KNEE. SALES MANAGER CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18824584 ↗
• InjuryMay 25, 2023Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  REVISION FROM MEDIAL UNI TO TOTAL KNEE REPLACEMENT. THE TIBIAL IMPLANT WAS LOOSE WITH MINIMAL BONDING TO THE CEMENT MANTLE. FEMUR WAS WELL FIXATED. PATIENT PRESENTED WITH MEDIAL KNEE PAIN. LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17000851 ↗
• InjuryJun 30, 2022Osseointegration Problem; Osseointegration Problem

  RESTORIS PKA WAS REVISED AFTER A PATIENT FALL AND SUBSEQUENT LOOSENING OF THE TIBIAL COMPONENT. LEFT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14878874 ↗
• InjuryMar 9, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A REVISION. PATIENT HAD A LEFT MAKO PARTIAL KNEE (RESTORIS) INSITU APPROXIMATELY 12 MONTHS OLD. THEY PRESENTED WITH MEDIAL PAIN, MRI SHOWED MEDIAL TIBIAL LOOSENING. INTRA OP TIBIAL BASEPLATE LIFTED OFF WITH NO SIGN OF CEMENT INTERDIGITATION. PRIMARY TRIATHLON KNEE IMPLANTED.

  Patient problems: Pain

  MAUDE report 11447284 ↗
• InjuryDec 11, 2020Break; Break

  MAKO BASEPLATE WAS REVISED AND WAS BROKEN IN 2 PIECES.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10992246 ↗

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