RESTORIS 180603Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486000691), received between Mar 18, 2019 and Aug 14, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Due to factors such as the use of high-viscosity bone cement during implantation, the surgeon applied excessive impaction, resulting in a fracture of the tibial condyle. The procedure was completed by switching to total knee arthroplasty (TKA).

  Patient problems: Bone Fracture(s)

  MAUDE report 50251866 ↗
• InjuryOct 20, 2025Osseointegration Problem; Osseointegration Problem

  AS REPORTED VIA MEDWATCH MW5176277: I HAD A PARTIAL KNEE REPLACEMENT IN 2023. I BEGAN HAVING INCREASED PAIN, INSTABILITY, AND A NOTICEABLE DEFORMITY IN THE KNEE WHEN IT WAS FLEXED IN THE EARLY SPRING OF 2024. A CT SCAN IN MAY SHOWED LOOSENING AND BONE LYSIS. IT QUICKLY WORSENED TO THE POINT WHERE I COULD FEEL THE KNEE JOINT SLIDING OVER MY TIBIA EVERY TIME I SHIFTED MY WEIGHT FORWARD. I HAD A REVISION TO A TOTAL KNEE REPLACEMENT IN 2024. THE OPERATIVE REPORT OF THE REVISION STATED "SIGNIFICANT POLYWEAR" AND "GROSS LOOSENING OF HER TIBIAL IMPLANT." IT WAS ALSO NOTED THAT I WAS "ACL (ANTERIOR CRUCIATE LIGAMENT) DEFICIENT" AND HAD "FULL THICKNESS CARTILAGE LOSS IN THE REMAINING COMPARTMENTS." THE PHYSICIAN'S ASSISTANT THAT ASSISTED IN THE SURGERY TOLD ME THE NEXT MORNING THAT HE LIFTED THE IMPLANT OUT WITH ONE FINGER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23334640 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Loss of Osseointegration

  MAKO PKA REVISED DUE TO LOOSE BASEPLATE. PATIENT SOUGHT TREATMENT FOR PAIN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10759704 ↗
• 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 9876917 ↗
• InjuryMar 18, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S LEFT PARTIAL KNEE WAS REVISED DUE TO SUBSIDENCE OF THE BASEPLATE. A MAKO PARTIAL KNEE WAS REVISED TO A TRIATHLON TOTAL KNEE CONSTRUCT INCLUDING PATELLA. REP PROVIDED PRIMARY AND REVISION IMPLANT SHEETS AS WELL AS X-RAYS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8429285 ↗

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