RESTORIS 180503Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000554), received between Dec 3, 2018 and Apr 3, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Osseointegration Problem; Osseointegration Problem

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21762223 ↗
• InjuryJun 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED FEMUR OF UNI PKA. CASE TYPE:PKA (MICS).

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10105422 ↗
• InjuryMar 25, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING (IT WAS NOT REPORTED TO THE REP WHICH DEVICE(S) EXPERIENCED LOOSENING. NO POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS REPORTED TO THE REP). THE PATIENT'S MAKO PKA WAS REVISED TO A TOTAL CR KNEE. REP PROVIDED EXPLANT PICTURES, PRIMARY AND REVISION USAGE SHEETS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9876914 ↗
• InjuryDec 3, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS REVISED DUE TO LOOSENING AFTER PATIENT COMPLAINT OF PAIN. UPDATE: THE FEMORAL COMPONENT WAS SLIGHTLY LOOSE. THE TIBIAL COMPONENT AND SPACER WERE WELL-FIXED AND WELL-POSITIONED.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8126620 ↗

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