RESTORIS 180703-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000851), received between Sep 12, 2017 and Aug 30, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 30, 2021Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  DURING THE FINAL IMPACTION OF THE INSERT, THE SURGEON WAS NOT ABLE TO FULLY SEAT THE ACTUAL INSERT. HE HAD IT REMOVED AND REPLACED WITH A NEW PIECE BUT HE HAD THE SAME OUTCOME AS SHOWN ON THE ATTACHED PHOTO "BEFORE FURTHER IMPACTION" DESPITE CLEARING AWAY THE SURROUNDING TISSUES. THIS PROCESS REPEATED THRICE AND FOR THE FINAL INSERT HE DECIDED TO DO A FURTHER IMPACT FROM THE MEDIAL SIDE AND THUS THE FINAL RESULT AS SHOWN IN ATTACHMENT "AFTER FURTHER IMPACTION". A THIN VISIBLE GAP AT THE MEDIAL SIDE CAN STILL BE SEEN AFTER THE FINAL FURTHER IMPACTION. AS WE HAVE EXHAUSTED ALL OUR 3X8MM POLYS THAT WAS PREP FOR THIS CASE, THE FINAL POLY HAD TO BE A 9MM INSTEAD. 10 AUG 2021 UPDATE: THE PATIENT WAS WELL AT THE MOMENT AND WAS DISCHARGED HOME. 19 AUG 2021 UPDATE : 3 ATTEMPTS AND 2 INSERTS WERE WASTED. LOT NUMBER : 12141118-1,12101118-1 ACTUAL INSERT USED TO COMPLETE THE CASE, CATALOG NUMBER: 180703-2, LOT NUMBER : 12551118-1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384656 ↗
• MalfunctionAug 30, 2021Difficult to Insert; Device Difficult to Setup or Prepare; Difficult to Insert; Device Difficult to Setup or Prepare

  DURING THE FINAL IMPACTION OF THE INSERT, THE SURGEON WAS NOT ABLE TO FULLY SEAT THE ACTUAL INSERT. HE HAD IT REMOVED AND REPLACED WITH A NEW PIECE BUT HE HAD THE SAME OUTCOME AS SHOWN ON THE ATTACHED PHOTO "BEFORE FURTHER IMPACTION" DESPITE CLEARING AWAY THE SURROUNDING TISSUES. THIS PROCESS REPEATED THRICE AND FOR THE FINAL INSERT HE DECIDED TO DO A FURTHER IMPACT FROM THE MEDIAL SIDE AND THUS THE FINAL RESULT AS SHOWN IN ATTACHMENT "AFTER FURTHER IMPACTION". A THIN VISIBLE GAP AT THE MEDIAL SIDE CAN STILL BE SEEN AFTER THE FINAL FURTHER IMPACTION. AS WE HAVE EXHAUSTED ALL OUR 3X8MM POLYS THAT WAS PREP FOR THIS CASE, THE FINAL POLY HAD TO BE A 9MM INSTEAD.(B)(6) 2021 UPDATE: THE PATIENT WAS WELL AT THE MOMENT AND WAS DISCHARGED HOME.(B)(6) 2021 UPDATE : 3 ATTEMPTS AND 2 INSERTS WERE WASTED. LOT NUMBER : 12141118-1,12101118-1ACTUAL INSERT USED TO COMPLETE THE CASE, CATALOG NUMBER: 180703-2, LOT NUMBER : 12551118-1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384652 ↗
• MalfunctionDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT INITIALLY GAVE THE INFORMED CONSENT FOR THE MAKO UNICOMPARTMENTAL KNEE SYSTEM TEST. THE PATIENT WAS LATER ENROLLED IN THE TRIAL. AT PRESENT, THE PATIENT IS IN THE RECOVERY STAGE ON THE EIGHTH DAY AFTER SURGERY. IT WAS LATER DISCOVERED THAT THE RESULTS OF BLOOD TEST WERE REPORTED: C-REACTIVE PROTEIN 38.95ML / L, SLIGHT REDNESS AROUND THE SURGICAL INCISION, AND SLIGHTLY HIGHER SKIN TEMPERATURE COMPARED WITH THE CONTRALATERAL SIDE. THE POSSIBILITY OF SURGICAL INCISION INFECTION WAS CONSIDERED.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 8195818 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A POLY EXCHANGE OF A PATIENT'S RIGHT KNEE DUE TO POSSIBLE INFECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6859385 ↗

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