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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM Back to Search Results
Model Number 02.07.0414SCF
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 december 2020: lot 174957: (b)(4) items manufactured and released on 16-jan-2018.Expiration date: 2022-12-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
 
Event or Problem Description
The patient came in, 5 months after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon performed an i&d and poly swap.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10998944
Report Number3005180920-2020-00923
Device Sequence Number10960557
Product Code JWH
UDI-Device Identifier07630030817878
UDI-Public07630030817878
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103170
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 company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/12/2020
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 Date12/17/2022
Device Model Number02.07.0414SCF
Device Catalogue Number02.07.0414SCF
Device Lot Number174957
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/20/2020
Initial Report FDA Received Date12/13/2020
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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