RESTORIS 180705-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486000912), received between Feb 22, 2019 and Aug 24, 2020 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2020Fracture; Fracture

  IT WAS REPORTED BY THE DISTRIBUTOR THAT SURGEON WAS ABOUT TO IMPLANT THE INSERT AS USUAL. HOWEVER, UPON IMPACT, THE INSERT DID NOT APPEAR TO SIT VERY WELL ON THE TIBIA TRAY. HENCE, THE SURGEON FURTHER EXAMINE AND REALISE THE INSERT HAS CRACKED. HENCE, HE REQUESTED FOR ANOTHER NEW INSERT WHILE ATTEMPT TO REMOVE THE CRACKED INSERT. THIS IS THE PRIMARY SURGERY. SURGERY DELAYED FOR 5 TO 10MINS. HOSPITAL: SGH, CASE NO: (B)(4). CATALOG NUMBER : 180705-1. LOT / SERIAL NUMBER : (B)(4). PRODUCT IS AVAILABLE FOR RETURN FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10443225 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A SIZE 5X8 RESTORIS ONLAY TIBIAL INSERT WAS SWAPPED OUT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8571498 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A MAKO RESTORIS 5X8 ONLAY TIBIAL INSERT WAS IMPLANTED. UPDATE 04/FEBRUARY/2019: SPOKE TO REP. AN I&D WITH WASHOUT AND POLY SWAP WAS PERFORMED DUE TO SUSPICION OF INFECTION (IT WAS NOT REPORTED TO THE REP WHETHER THE INFECTION WAS CLINICALLY CONFIRMED OR NOT). A 5X8 ONLAY TIBIAL INSERT WAS EXCHANGED FOR ANOTHER DEVICE OF THE SAME CATALOG NUMBER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361410 ↗

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