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-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R; FIXED 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-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R; FIXED TIBIAL INSERT Back to Search Results
Model Number 02.12.0212FR
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 07/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 july 2021: lot 141801: (b)(4) items manufactured and released on 22-may-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event since 01-jan-2017.
 
Event or Problem Description
5 years and 3 months after primary revision surgery for liner fixation screw unscrewing.Liner revised successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12231414
Report Number3005180920-2021-00643
Device Sequence Number19736003
Product Code JWH
UDI-Device Identifier07630030826184
UDI-Public07630030826184
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/27/2021
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 Date03/31/2019
Device Model Number02.12.0212FR
Device Catalogue Number02.12.0212FR
Device Lot Number141801
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date07/27/2021
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;
-
-