RESTORIS 180606Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00848486000721), received between Jul 26, 2018 and Mar 24, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Fracture; Loss of Osseointegration

  THE FOLLOWING WAS REPORTED: "PKA REVISION (RESTORIS), WHEN REMOVING TIBIAL BASEPLATE WAS SNAPPED IN HALF. THE SURGEON THINKS IT SNAPPED WHEN HE REMOVED IT WITH AN OSTEOTOME BUT IS UNSURE IF WAS ALREADY CRACKED INSITU."

  Patient problems: Arthritis; Inadequate Osseointegration; Insufficient Information; Pain

  MAUDE report 24681661 ↗
• InjuryDec 1, 2025Fracture; Fracture

  REVISED AN LEFT MEDIAL MCK KNEE DUE TO TIBIAL BASEPLATE IMPLANT FRACTURE. HE REVISED TO A TOTAL KNEE. HE SAID THE PATIENT DIDN'T CLAIM TO HAVE A TRAUMATIC EVENT TO PARTICULARLY CAUSE IT.

  Patient problems: Insufficient Information

  MAUDE report 23680169 ↗
• InjuryJul 10, 2025Fracture; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2021 THE PATIENT UNDERWENT A MAKO ROBOTIC ASSISTED LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY. IT IS ALLEGED ON OR ABOUT (B)(6) 2022, THE TIBIAL COMPONENT HAD FRACTURED AND HE UNDERWENT A TOTAL KNEE REVISION ON (B)(6) 2022.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468988 ↗
• InjuryNov 21, 2024Fracture; Fracture

  MAKO UNI TIBIAL TRAY FRACTURED INTO TWO PIECES. REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20744574 ↗
• InjuryJan 26, 2023Fracture; Fracture

  IT WAS REPORTED A RESTORIS LEFT MEDIAL PKA WAS REVISED DUE TO A BROKEN BASEPLATE (NO DIRECT CAUSE FOR BREAKAGE WAS REPORTED TO THE REP). PATIENT WAS CONVERTED TO A TKA WITH STEM AND AUGMENTS ON THE TIBIAL SIDE.

  Patient problems: Bone Fracture(s); Fall; Insufficient Information; Pain

  MAUDE report 16245566 ↗
• InjuryJan 18, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "REVISED A MAKO LEFT MEDIAL UNI DUE TO TIBIAL LOOSENING AND DISEASE PROGRESSION". PATIENT WAS REVISED TO A TKA.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16193445 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING THE CEMENTING OF THE FINAL IMPLANTS, DR. SUSPECTED A POTENTIAL FRACTURE IN THE TIBIA. HE MADE A COMMENT ABOUT THE BLUE TIP BREAKING OFF OF THE TIBIAL BASEPLATE IMPACTOR WHILE HE WAS SLIDING THE IMPACTOR FROM THE POSTERIOR PART OF THE BASEPLATE TO ANTERIOR AND THAT SOME OF THE FINAL IMPACTIONS MAY HAVE BEEN METAL ON METAL. HE PUT IN THE FEMORAL AND INSERT TRIALS AND PLACED THE LEG IN EXTENSION WITH AN AXIAL LOAD TO FULLY SEAT THE CEMENTED TIBIA BASEPLATE RATHER THAN CONTINUE TO USE AN IMPACTOR. HE NOTICED THE TIBIAL CHECKPOINT SEEMED LOOSE AND WAS EASILY ABLE TO PULL IT OUT. ONCE REMOVED, HE WAS ABLE TO CONFIRM THERE WAS A FRACTURE AND ORDERED AN X-RAY. AN X-RAY CONFIRMED A FRACTURE FROM THE TIBIA PLATEAU EXTENDING TO WHERE THE POSITION OF THE TIBIA CHECKPOINT WAS SEATED. DR. SUSPECTS THE FRACTURE PROPAGATED AT THE TIBIAL KEEL AND WORKED ITS WAY ANTERIOR TO THE LATERAL SIDE OF THE PEG AND DOWN TO THE CHECKPOINT, ALTHOUGH HE WAS NOT ABLE TO CONFIRM IT WENT TO THE KEEL BECAUSE THE IMPLANT WAS ALREADY CEMENTED DOWN. A TRAUMA SURGEON WAS CALLED IN TO REPAIR THE FRACTURE. FOLLOWING THIS, ALIGNMENT WAS CHECKED IN KINEMATIC ANALYSIS AS WELL AS WALKING THE GREEN PROBE OVER THE BASEPL

  Patient problems: Bone Fracture(s)

  MAUDE report 8608735 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MAKO PARTIAL KNEE REQUIRED A REVISION TO A TOTAL KNEE. UPDATE 18/MARCH/2019: SPOKE TO REP. PATIENT WAS REVISED DUE TO TIBIAL COLLAPSE. SURGEON REPORTED THE PATIENT DID NOT FOLLOW MEDICAL ADVICE POST-OPERATIVELY AND BUILT A BARN. THE UNUSUAL FORCES INVOLVED CAUSED THE FAILURE. THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES OR PROCEDURES. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 8493594 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT'S LEFT MEDIAL UNI TIBIAL COMPONENT AND POLY WERE REVISED DUE TO LOOSE CEMENT. A MAKO 6 UNI BASEPLATE PART 180606 AND 6X9 POLY PART 180736-2 WERE EXPLANTED. INITIAL PROCEDURE WAS DONE AT A DIFFERENT FACILITY, NO IMPLANT RECORDS, LOTS OR PART NUMBERS AVAILABLE DUE TO NOT BEING IN THE RECORDS. NO IMPLANTS RETURNED PER HOSPITAL POLICY. AWARENESS DATE IS (B)(6) 2018. NO FURTHER INFORMATION COMING". PATIENT WAS REVISED TO A TKA WITH NAVIGATION.

  Patient problems: Injury

  MAUDE report 7725209 ↗

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