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 3/12 MM R
  • 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 3/12 MM R Back to Search Results
Model Number 02.12.0312FR
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-mar-2020: lot 178760: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 14.03.2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting discomfort due to laxity in the knee 5 months after primary.The cause of the laxity is unknown.The surgeon revised the medacta sphere insert flex right 12mm s3 with a medacta sphere insert flex right 17mm s3.The surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key9872421
Report Number3005180920-2020-00182
Device Sequence Number524883
Product Code JWH
UDI-Device Identifier07630030826382
UDI-Public07630030826382
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/24/2020
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 No Information
Device Expiration Date03/14/2023
Device Model Number02.12.0312FR
Device Catalogue Number02.12.0312FR
Device Lot Number178760
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2020
Initial Report FDA Received Date03/24/2020
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;
Patient Age80 YR
-
-