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Mako 180737-1Recalls & reported problems

Mako Surgical Corp. · Tibial Bearing Insert · Class 2 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486016647), received between Aug 14, 2018 and Aug 9, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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

  • Insufficient Device Problem Information2
  • Degraded1
  • Device Difficult to Setup or Prepare1
  • Naturally Worn1

Patient problems

  • Ambulation or Postural Difficulties1
  • Bacterial Infection1
  • Insufficient Information1
  • No Consequences Or Impact To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 9, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

    IT WAS REPORTED THAT THE PATIENT'S RIGHT MEDIAL PKA WAS CONVERTED TO A TKA DUE TO A FRACTURED BASEPLATE WHICH LED TO BOWING OF THE INSERT. PATIENT'S BMI WAS CITED AS A CAUSE OR CONTRIBUTING FACTOR. INTRA-OPERATIVELY, THE BASEPLATE WAS FOUND TO BE IN 5 PIECES. ALL COMPONENTS WERE REVISED.

    Patient problems: Ambulation or Postural Difficulties; Insufficient Information

    MAUDE report 15190751 ↗
  • InjuryMar 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT MAKO PKA DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY IMLANT SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 11551855 ↗
  • InjuryOct 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    THE DOCTOR PERFORMED AN I&D INSERT SWAP ON A PATIENT DUE TO INFECTION OF A MAKO RIGHT MEDIAL UNI. ORIGINAL DOS WAS (B)(6) 2020.

    Patient problems: Bacterial Infection

    MAUDE report 10665864 ↗
  • MalfunctionAug 14, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

    AS REPORTED: "DURING THE CASE THERE WAS AN ISSUE WITH THE FIRST 7X8MM TIBIAL POLY USED AS THE POLY WOULD NOT LOCK INTO PLACE PROPERLY. A SECOND 7X8 POLY WAS OPENED AND LOCKED INTO PLACE USING SAME TECHNIQUE WITH NO ISSUES ON FIRST TRY". REP CONFIRMED A SURGICAL DELAY OF 1 MINUTE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7780539 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices →

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