RESTORIS 180615Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848486000783), received between Jun 22, 2020 and Apr 20, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Fracture; Osseointegration Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT HAD A REVISION FROM A PARTIAL KNEE TO TOTAL KNEE DUE TO A FRACTURED BASEPLATE. IT WAS NOTED THAT THE BASEPLATE WAS FRACTURED DOWN THE CENTER.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24930509 ↗
• InjuryJan 9, 2025Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  REVISION OF RESTORIS PARTIAL KNEE REPLACEMENT TO TOTAL KNEE REPLACEMENT. REASON FOR REVISION: SUBSIDENCE OF TIBIAL IMPLANT. OUTCOME OF REVISION: SIZE 5 TRIATHLON CR CEMENTED FEMUR, SIZE 6 UNIVERSAL BASEPLATE, 12 X 50MM STEM, 6 X 9MM CS INSERT, 35 ASYMMETRIC PATELLA. NOTE: PRIMARY PROCEDURE USED MAKO. REVISION PROCEDURE DID NOT USE MAKO. PRIMARY OPERATION PKA 3.0. (B)(6) PRIMARY OPERATION.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 21111412 ↗
• InjuryOct 21, 2024Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING WAS REPORTED "REVISED A RIGHT MEDIAL MCK UNI DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS."

  Patient problems: Inadequate Osseointegration

  MAUDE report 20496345 ↗
• MalfunctionNov 21, 2022Fracture; Fracture

  PATIENT COMPLAINED OF PAIN. HAD X RAY AND DISCOVERED TIBIAL BASEPLATE FRACTURE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15833402 ↗
• InjuryOct 19, 2022Fracture; Fracture

  TIBIAL BASEPLATE ON RESTORIS MCK MEDIAL UNI HAS CRACKED IN SITU. ORIGINAL OPERATION DATE FRIDAY (B)(6) 2021. ISSUE NOTICED MID-SEPTEMBER BY SURGEON ON X-RAY AND REPORTED TO REP. IMPLANT WAS A SIZE 5 RM/LL ONLAY TIBIAL BASEPLATE. PLAN IS TO PULL OUT IMPLANT AND REVISE TO TOTAL KNEE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15632145 ↗
• InjuryNov 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS CONVERTED FROM A PKA TO A TKA DUE TO A BROKEN TIBIAL BASEPLATE. SURGEON REPORTED POSSIBLE CONTRIBUTING FACTOR IS THAT THE PATIENT IS PRONE TO FALLING. THE FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT OR FEMORAL COMPONENT.

  Patient problems: Fall

  MAUDE report 12867644 ↗
• InjuryJan 4, 2021Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A RIGHT MAKO MEDIAL UNI ORIGINALLY DONE ON (B)(6) 2017 DUE TO PAIN/TIBIAL LOOSENING. HE REVISED TO A PRIMARY TRIATHLON. HE NOTED THE TIBIA WAS "EASY TO GET OUT." UPDATE 14/DECEMBER/2020: SPOKE TO REP, PATIENT WAS REVISED FROM A MAKO UNI KNEE (WITH CEMENTED FEMORAL AND TIBIAL COMPONENTS) TO A TRIATHLON TKA. REVISION PERFORMED ROBOTICALLY. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL COMPONENT OR INSERT. REP PROVIDED USAGE REPORTS, X-RAYS, AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11114410 ↗
• 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; Insufficient Information; Joint Dislocation

  MAUDE report 10181540 ↗

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