RESTORIS 180705-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000929), received between Aug 29, 2017 and Aug 11, 2020 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WENT TO DOCTOR WITH INCREASING PAIN, WAS ASPIRATED AND FOUND TO HAVE SIGNIFICANT INFECTION. APPROXIMATELY, 1 WEEK LATER, IMPLANT WAS REMOVED AND REPLACED WITH ANTIBIOTIC SPACER. PATIENT WAS HOSPITALIZED FOR 4 DAYS, AND THEN 5 DAYS WHEN STAGE 2 REVISION WAS DONE.

  Patient problems: Injury; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10390474 ↗
• InjuryJul 20, 2020Naturally Worn; Naturally Worn

  RESTORIS IMPLANTS WERE REVISED DUE TO FEMORAL AND TIBIAL IMPLANT LOOSENING. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017 AT (B)(6) PRIVATE HOSPITAL (B)(6). REVISION WAS DONE ON (B)(6) 2020 AT THE SAME HOSPITAL AND BY THE SAME SURGEON. NEW IMPLANTS OF THE SAME TYPE WERE IMPLANTED. FEMORAL AND TIBIAL COMPONENT OF THE SAME SIZE WERE USED, THE INSERT THICKNESS WAS CHANGED FROM 9 MM TO 12 MM. THE REVISION WAS CARRIED OUT SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10298341 ↗
• InjuryJul 30, 2018Unstable; Dent in Material; Scratched Material; Insufficient Device Problem Information; Unstable; Dent in Material; Scratched Material; Insufficient Device Problem Information

  PATIENT ADMITTED FOR POLY EXCHANGE, PLAN TO INCREASE POLY THICKNESS DUE TO JOINT LOOSENESS.

  Patient problems: Injury

  MAUDE report 7732537 ↗
• MalfunctionAug 29, 2017Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  SURGEON MADE A COMPLAINT ABOUT THE DESIGN OF THE TIBIAL POLY LOCKING MECHANISM. HE DESCRIBED THE PROBLEM BEING THAT IT IS DIFFICULT TO ENGAGE THE POSTERIOR ASPECT OF THE POLY INTO THE TIBIAL BASEPLATE. APPROXIMATE DELAY WAS 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6826738 ↗

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