Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM Back to Search Results
Catalog Number 02.09.0214H
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 04/29/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 april 2018.Lot 143009: 25 items manufactured and released on 16 july 2014.Expiration date: 2019-06-30.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 3 years after primary the surgeon swapped the patient liner for a knee instability.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7442502
Report Number3005180920-2018-00249
Device Sequence Number11204850
Product Code KRO
UDI-Device Identifier07630030825064
UDI-Public07630030825064
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number02.09.0214H
Device Lot Number143009
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2018
Initial Report FDA Received Date04/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age46 YR
-
-