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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0414FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
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MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0414FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L Back to Search Results
Model Number 02.12.0414FL
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 02/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2020.Lot 170300: (b)(4) items manufactured and released on 05-apr-2017.Expiration date: 2022-03-09.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 pain due to stiffness in the knee.The surgeon revised the 14mm insert with a 13mm insert almost 2 years after primary.The surgery was completed successfully.
 
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Brand Name
GMK-SPHERE 02.12.0414FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
Common Device Name
TIBIAL INSERT FIXED
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9882637
Report Number3005180920-2020-00196
Device Sequence Number2794048
Product Code JWH
UDI-Device Identifier07630030826610
UDI-Public07630030826610
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121416
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/26/2020
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 Date03/09/2022
Device Model Number02.12.0414FL
Device Catalogue Number02.12.0414FL
Device Lot Number170300
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2020
Initial Report FDA Received Date03/26/2020
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;
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