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-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT
  • 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-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM; KNEE TIBIAL INSERT Back to Search Results
Model Number 02.07.0410SF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 10/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2020: lot 174620: 100 items manufactured and released on 29-nov-2017.Expiration date: 2022-11-08.No anomalies found related to the problem.To date, 92 items of the same lot have been already sold with one other similar event reported.
 
Event or Problem Description
The patient came in, 7 months after primary surgery, due to signs of an infection and the pathogen was unknown.The surgeon performed a knee washout and poly-swap and the surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM
Common Device Name
KNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10895796
Report Number3005180920-2020-00831
Device Sequence Number19640563
Product Code JWH
UDI-Device Identifier07630030817663
UDI-Public07630030817663
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 11/24/2020
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 Date11/08/2022
Device Model Number02.07.0410SF
Device Catalogue Number02.07.0410SF
Device Lot Number174620
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/28/2020
Initial Report FDA Received Date11/24/2020
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;
-
-