Skip to content

GMK Sphere Total Knee System 02.12.0120FLRecalls & reported problems

Medacta International SA · Tibial Insert Fixed SPHERE Flex #1/20 mm L · Class 2 · Implant

All models of GMK Sphere Total Knee System (209)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030826092), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Device problems

  • Break1
  • Loose or Intermittent Connection1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 19, 2018Break; Loose or Intermittent Connection

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017. THE PATIENT CAME IN DUE TO LAXITY AND THE SURGEON PERFORMED A POLY SWAP ON (B)(6) 2018 [COMPLAINT (B)(4)]. THE SURGEON TOOK AN X-RAY FOR A POST-OP FOLLOW UP AND NOTICED THAT THE INSERT SCREW WAS BROKEN. THE REVISION SURGERY WILL TAKE PLACE ON (B)(6) 2018.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 8084542 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page