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-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM
  • 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-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM Back to Search Results
Model Number 02.07.0423SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08.June.2021: lot 2003170: 25 items manufactured and released on 3-aug-2020.Expiration date: 2025-07-09.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
2 days after the previous revision surgery (due to infection) the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12039382
Report Number3005180920-2021-00520
Device Sequence Number17144892
Product Code JWH
UDI-Device Identifier07630030818134
UDI-Public07630030818134
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/22/2021
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 Date07/09/2025
Device Model Number02.07.0423SCF
Device Catalogue Number02.07.0423SCF
Device Lot Number2003170
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/27/2021
Initial Report FDA Received Date06/22/2021
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;
-
-