RESTORIS 180617Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486000806), received between Jun 11, 2019 and Aug 5, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryAug 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MEDIAL PKA WAS CONVERTED TO A TKA DUE TO A FRACTURED BASEPLATE WHICH LED TO BOWING OF THE INSERT. PATIENT'S BMI WAS CITED AS A CAUSE OR CONTRIBUTING FACTOR. INTRA-OPERATIVELY, THE BASEPLATE WAS FOUND TO BE IN 5 PIECES. ALL COMPONENTS WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15174678 ↗
• 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 TRAILING 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 10812187 ↗
• InjuryJun 11, 2019Crack; Crack

  GOT A TEXT FROM SURGEON WITH PICTURE OF WHAT APPEARS TO BE A CRACK IN THE MAKO TIBIAL BASEPLATE. UPDATE 15/MAY/2019: AS REPORTED IN PRODUCT NOT AVAILABLE - WHY NOT: "STILL IN PATIENT". UPDATE: NO PLAN FOR REVISION AT THIS TIME. PATIENT REPORTED KNEE PAIN. KNEE IS STABLE.

  Patient problems: Pain

  MAUDE report 8687278 ↗

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-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-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-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