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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 5/14MM
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MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM Back to Search Results
Catalog Number 02.07.0514SCF
Health Effect - Clinical Codes Hematoma (1884); Joint Swelling (2356)
Date of Event 10/09/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2017.Lot 140488: (b)(4) items manufactured and released on 06 may 2014.Expiration date: 2019-02-28.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
The patient came in complaining swelling.The surgeon determined that a hemotoma had developed causing the swelling.The surgeon performed a revision replacing the 14mm size poly with a 12mm.The surgery was completed successfully.
 
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Brand Name
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 5/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7008639
Report Number3005180920-2017-00638
Device Sequence Number1196946
Product Code JWH
UDI-Device Identifier07630030818455
UDI-Public07630030818455
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 Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/08/2017
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 Date02/28/2019
Device Catalogue Number02.07.0514SCF
Device Lot Number140488
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/09/2017
Initial Report FDA Received Date11/08/2017
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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