RESTORIS 180505Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000578), received between Jun 18, 2018 and Jul 20, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2020Loss of Osseointegration; Loss of Osseointegration

  RESTOR IS IMPLANTS WERE REVISED DUE TO FEMORAL AND TIBIAL IMPLANT LOOSENING. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017 AT (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 10296324 ↗
• InjuryMar 4, 2020Failure to Osseointegrate; Failure to Osseointegrate

  REVISION OF RESTORIS MEDIAL UNICOMP DUE TO LOOSENING. CEMENT APPEARED NOT TO HAVE BONDED WITH NATIVE BONE. REVISED TO A TRIATHLON TOTAL KNEE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9786119 ↗
• InjuryJun 25, 2018Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  SURGEON EXPRESSED THAT THE PREVIOUS MEDICAL DONE ON THE PATIENTS LEFT SIDE ON (B)(6) WAS DIFFICULT AND THERE SEEMED TO BE SOMETHING WRONG WITH THE REGISTRATION. AFTER LOOKING INTO THE CASE WHICH WAS ON THE ROBOT STILL, IT WAS CLEAR THAT ALTHOUGH IT WAS STATED TO BE A LEFT LEG ON THE ROBOT IT WAS ACTUALLY THE RIGHT SIDE WAS SEGMENTED AND WAS USED FOR THE LEFT LEG OPERATION. THEREFORE ACTUALLY THE RIGHT LATERAL SCAN WAS USED FOR THE LEFT MEDIAL OPERATION. THE RIGHT LATERAL SEGMENTED BONE WAS USED TO CUT THE LEFT MEDIAL BONE. THEREFORE CUTTING AND POSITIONING OF THE IMPLANT LIKELY NOT IDEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635442 ↗
• InjuryJun 18, 2018Malposition of Device; Malposition of Device

  PATIENT CALLED AND STATED THAT HE HAD A BILATERAL MAKO PLASTY ON (B)(6) 2012. PATIENT STATED THAT ON OR ABOUT AUGUST, 2017 HE STARTED EXPERIENCING PAIN IN HIS RIGHT KNEE. HE WENT TO GEISINGER AND HAD X-RAYS AND FOUND OUT THAT HE HAS A FAILED TIBIA. EVENT UPDATE PER MEDICAL REVIEW "AN AP X-RAY TAKEN ON (B)(6) 2018 DEMONSTRATES LUCENCY BENEATH THE LATERAL ASPECT OF THE TIBIAL COMPONENT CONSISTENT WITH LOOSENING. THE FEMORAL COMPONENT IS MEDIALLY POSITIONED IN COMPARISON TO THE LOCATION OF THE TIBIAL IMPLANT."

  Patient problems: Pain

  MAUDE report 7610518 ↗

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