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RESTORIS 180518Recalls & reported problems

Mako Surgical Corp. · MCK Femoral Component · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486000677), received between Jul 19, 2017 and Jul 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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

Device problems

  • Difficult to Insert1
  • Insufficient Device Problem Information1

Patient problems

  • Injury1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 9, 2018Difficult to Insert; Difficult to Insert

    AS REPORTED: WHEN GOING TO IMPLANT THE FEMUR COMPONENT THE SURGEON STATED THAT WHEN THE POSTERIOR POST WENT IN THE ANTERIOR POST WOULD NOT FIXATE INTO THE HOLE. TRIED MULTIPLE TIMES WHEN CEMENTING COMPONENT IN AND IT WOULD NOT SEAT INTO THE POST HOLES CORRECTLY. PLEASE NOTE THAT THE TRIAL 8 RM FEMUR FIT INTO PLACE PERFECTLY ON THE FIRST TRY. WE CONFIRMED POST HOLES WERE COMPLETELY BURRED AND THERE WERE NO ISSUES WITH ARRAY MOVEMENT THROUGHOUT THE CASE. ANOTHER 8 RM FEMUR IMPLANT WAS OPENED AND CEMENTED INTO PLACE WITH NO ISSUES WITH THE POST HOLES SEATING. PKA CASE DELAYED 5 MINUTES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7671332 ↗
  • InjuryJul 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    REVISION REQUIRED OF MAKO UNI KNEE.

    Patient problems: Injury

    MAUDE report 6725828 ↗

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

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.