RESTORIS 180601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486001995), received between Aug 26, 2020 and Aug 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2020Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE LEFT KNEE. AS REPORTED IN PI (B)(4): IT WAS REPORTED BY SURGEON THAT PRE OP X-RAYS SHOWED MEDIAL COMPARTMENT WEAR. ALL THE STANDARD CRITERIA FOR MEDIAL COMPARTMENT ARTHROPLASTY WERE FULFILLED AND SURGEON PERFORMED A BILATERAL PARTIAL KNEE MEDIAL MAKOPLASTY. PRIMARY SURGERY PERFORMED ON (B)(6) 2017, BY DR. THE SURGEON REPORTED THAT THE CEMENTING TECHNIQUE IS AS WHAT HE WOULD DO FOR ALL MEDIAL MAKO KNEES AND HAVE HAD NO ISSUES. PATIENT POST OP X-RAYS WERE GOOD POSITION. EVEN HER POST OP MRI DONE ON HER KNEES 9 MONTHS AFTER POST SURGERY SHOWED NO LOOSENING AND STABLE IMPLANTS, NOR EDEMA. POST OP X-RAYS SHOWED THE IMPLANTS TO BE PERFECTLY PLACED. HOWEVER IN 2019 IT WAS NOTED THAT SHE DEVELOPED ACCELERATED LOOSENING OF BOTH MEDIAL IMPLANTS AND THIS RESULTED IN A BILATERAL REVISION TOTAL KNEE ARTHROPLASTY. THE REVISION WAS PERFORMED BY DR (B)(6) 2019. THE OPERATIVE NOTES SHOWED BILATERAL EXTENSIVE POLYETHYLENE WEAR WITH RESULTANT EXTENSIVE SYNOVITIS AND LOOSENING. REVISION PERFORMED USING NON STRYKER PRODUCT. NO DETAILS PROVIDED AS PATIENT WENT TO CONSULT ANOTHER SURGEON. UPDATED: 03 AUG 2020 - REFER IMPLANT PICTURE IN INTAKE TAB. RECENTLY, THE PATIENT CAME BACK TO VIS

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10454103 ↗

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