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 UC FIXED SIZE 5 / 12 MM
  • 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 UC FIXED SIZE 5 / 12 MM Back to Search Results
Catalog Number 02.07.0512FUC
Health Effect - Clinical Code Pain (1994)
Date of Event 02/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2018; lot 114251: (b)(4) items manufactured and released on 10 february 2012, expiration date: 2016-12-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
On (b)(6) 2018 medacta us has been informed by the sales agent that the patient came in complaining of pain.On (b)(6) 2018 the surgeon swapped the poly as planned.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM
Common Device Name
TIBIAL INSERT UC FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7362194
Report Number3005180920-2018-00172
Device Sequence Number1426751
Product Code JWH
UDI-Device Identifier07630030818295
UDI-Public07630030818295
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K090988
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/22/2018
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 Date12/31/2016
Device Catalogue Number02.07.0512FUC
Device Lot Number114251
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 02/22/2018
Initial Report FDA Received Date03/22/2018
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 Age62 YR
-
-