GMK SpheriKA Cementless 02.12.KA171LRecalls & reported problems

Medacta International SA · GMK SpheriKa Femur Porous TiGrowthC+HA S1+L · Class 2 · Implant

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 07630345799289), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Dislodged or Dislocated1

Patient problems

Joint Dislocation1

Recent adverse event reports

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

InjuryJan 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE FEMUR FROM THE TIBIAL INSERT DUE TO LIGAMENT LOOSENESS. ABOUT 7 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT'S REVISION SURGERY INCLUDED REVISING THE FEMUR, TIBIA, AND TIBIAL INSERT COMPONENTS AND GMK REVISION COMPONENTS WERE THEN IMPLANTED AND A SEMI-CONSTRAINED INSERT WAS USED. NO TRAUMATIC EVENT WAS REPORTED.
Patient problems: Joint Dislocation
MAUDE report 21227337 ↗

Device details

UDI-DI	`07630345799289`
Brand	GMK SpheriKA Cementless
Model	02.12.KA171L
Company	Medacta International SA
Product code	MBH · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Class	Class 2
FDA submission	K223548
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 31, 2023

Device type (GMDN): Coated knee femur prosthesis

A sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.

Other Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices

ATTUNE 1512-14-050
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
106 reports
ATTUNE 1504-40-205
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall53 reports
ATTUNE 1504-40-105
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall46 reports
ATTUNE 1547-06-001
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall37 reports
ATTUNE 1513-12-060
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
72 reports
Triathlon 5521-B-300
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall19 reports
Triathlon 5531-G-709-E
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall19 reports
ATTUNE 1512-16-080
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall16 reports

All Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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