RESTORIS 180515Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486000646), received between Jun 22, 2020 and Nov 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING A MEDIAL PARTIAL KNEE MAKO PROCEDURE PERFORM BY THE SURGEON, HE COULD NOT GET THE POLYETHYLENE INSERT TO LOCK IN THE TIBIAL BASEPLATE POSTERIORLY. THE TRIAL BASEPLATE AND TRIAL POLY WAS ABLE TO FIT WITH LITTLE DIFFICULTY DURING THE TRIALING STAGE, HOWEVER THE FINAL IMPLANT POLY WOULD NOT LOCK IN TO THE FINAL BASEPLATE MECHANISM DESPITE THE SURGEONS EFFORTS. FOUR DIFFERENT POLYETHYLENE INSERTS WHERE USED WITH THE SAME OUTCOME. ULTIMATELY THE SURGEON MADE THE DECISION TO COMPLETE THE CASE WITHOUT ACHIEVING COMPLETE LOCKING OF THE INSERT POSTERIORLY ¿ IT ACHIEVED LOCKING ANTERIORLY ON EACH OCCASION. 1H DELAY: UPDATE: TOURNIQUET WAS CONTINUED TO BE USED DURING THE DELAY BUT WAS TURNED OFF AT A TOURNIQUET TIME OF TWO HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10812270 ↗
• InjuryJun 22, 2020Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MAKO PARTIAL KNEE WAS REVISED DUE TO MEDIAL SUBSIDENCE OF THE FEMORAL COMPONENT, SUBSIDENCE OF THE TIBIAL COMPONENT, AND EXTREME POLY WEAR. SURGEON STATED THE OPINION THAT POLY WEAR/ DEBRIS WAS A CAUSE OR CONTRIBUTOR FOR FEMORAL SUBSIDENCE. PATIENT WAS REVISED TO A TOTAL KNEE. REP PROVIDED THE ORIGINAL USAGE REPORT AND EXPLANT PICTURES. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN, OTHERWISE THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 10181638 ↗

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