RESTORIS 180616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486000790), received between Aug 29, 2019 and Nov 19, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Osseointegration Problem; Osseointegration Problem

  REVISION OF RIGHT PARTIAL MEDIAL UNI TO RIGHT TOTAL KNEE. ORIGINAL SURGERY WAS RIGHT PARTIAL MEDIAL UNICOMPARTMENTAL KNEE DONE IN (B)(6) 2014 (EXACT DATE UNKNOWN). REASON FOR REVISION WAS TIBIAL COMPONENT WAS LOOSE. ALL THREE COMPONENTS (MCK FEMUR, MCK TIBIA, AND POLY) WERE REVISED AND REPLACED WITH TOTAL KNEE IMPLANTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20727578 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE IMPLANTS USED IN PATIENT 3 OF 3. (B)(6) MALE, SURGERY (B)(6) 2019. RIGHT KNEE. AS REPORTED BY SURGEON: ATTACHED ARE XRAYS OF THREE PATIENTS I PREVIOUSLY DISCUSSED. ALL HAVE CONCERNING RADIOLUCENCIES UNDERNEATH THE TIBIAL BASEPLATE THAT APPEARED SEVERAL MONTHS POST OP. THUS FAR, NONE HAVE REQUIRED REVISION BUT ALL HAVE SOME DEGREE OF PAIN (MOSTLY MEDIAL). AGAIN I NEVER SAW THIS PRIOR THE MICS TRANSITION. LET ME KNOW YOUR THOUGHTS AND IF ANY OTHER SURGEONS HAVE SEEN THIS ISSUE. MORE RECENTLY, I HAVE BEEN USING A 2MM DRILL TO PERFORATE THE SCLEROTIC TIBIAL SURFACE TO PROMOTE BETTER CEMENT INTERDIGITATION AND MY RESULTS SEEM TO BE MUCH BETTER. CASE TYPE: PKA 3.0.

  Patient problems: Pain

  MAUDE report 9794039 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE IMPLANTS USED IN PATIENT 2 OF 3. (B)(6) YO FEMALE, SURGERY (B)(6) 2019. AS REPORTED BY SURGEON: ATTACHED ARE XRAYS OF THREE PATIENTS I PREVIOUSLY DISCUSSED. ALL HAVE CONCERNING RADIOLUCENCIES UNDERNEATH THE TIBIAL BASEPLATE THAT APPEARED SEVERAL MONTHS POST OP. THUS FAR, NONE HAVE REQUIRED REVISION BUT ALL HAVE SOME DEGREE OF PAIN (MOSTLY MEDIAL). AGAIN I NEVER SAW THIS PRIOR THE MICS TRANSITION. LET ME KNOW YOUR THOUGHTS AND IF ANY OTHER SURGEONS HAVE SEEN THIS ISSUE. MORE RECENTLY, I HAVE BEEN USING A 2MM DRILL TO PERFORATE THE SCLEROTIC TIBIAL SURFACE TO PROMOTE BETTER CEMENT INTERDIGITATION AND MY RESULTS SEEM TO BE MUCH BETTER. CASE TYPE: PKA 3.0.

  Patient problems: Pain

  MAUDE report 9794038 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF A RESTORIS MEDIAL UNICOMPARTMENT KNEE TO A TOTAL KNEE REPLACEMENT. PATIENT HAD A REVISION UNDERTAKEN DUE TO PAIN UPON WALKING. FEMORAL COMPONENT APPEARED WELL FIXED, TIBIAL COMPONENT WAS EASILY MOVED DURING THE REVISION. ONCE IMPLANTS WERE REMOVED THE TIBIAL IMPLANT SHOWED NO VISIBLE SIGNS OF BONDING TO THE CEMENT NOR THE BONE. FEMUR WAS WELL FIXED. A TOTAL KNEE REPLACEMENT WAS COMPLETED SATISFACTORILY USING A TRIATHLON PS IMPLANT, WITHOUT DELAY.

  Patient problems: Injury; Pain

  MAUDE report 8947010 ↗

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