RESTORIS 180404Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486000424), received between Feb 11, 2019 and Apr 24, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Degraded; Degraded

  LEFT KNEE REVISION DONE TODAY. ON (B)(6) 2024), THE REVISION TODAY WAS DUE TO LATERAL JOINT PAIN IN THE KNEE. NO INFORMATION IS AVAILABLE FROM THE PRIMARY SURGERY FOR THIS PATIENT. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL. APR 18, 2024: INVESTIGATION OF DEVICE IMAGES SHOWED WEAR ON BOTH THE TIBIAL INSERT AND THE PATELLA.

  Patient problems: Pain

  MAUDE report 19170833 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. INITIAL PATIENT COMPLAINT WAS PAIN, SURGEON REPORTED THAT THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS AND THAT PROGRESSION OF THE PATIENT'S EXISTING DISEASE, CAUSING THE KNEE TO COLLAPSE INTO VALGUS. A PATELLOFEMORAL IMPLANT AND PATELLAR COMPONENT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Pain

  MAUDE report 10390468 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT MAKO TKA REVISION FROM MAKO PF DUE TO PROGRESSIVE OA.

  Patient problems: Injury

  MAUDE report 8329924 ↗

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