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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM Back to Search Results
Catalog Number 02.09.0314H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/23/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 april 2018.(b)(4).
 
Event or Problem Description
The patient came in due to signs of infection 1 month and two weeks after primary.The pathogen is unavailable.The surgeon washed out the knee and swapped the liner.The surgery was completed successfully.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7442494
Report Number3005180920-2018-00248
Device Sequence Number2156970
Product Code KRO
UDI-Device Identifier07630030825132
UDI-Public07630030825132
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/19/2018
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 Date04/23/2022
Device Catalogue Number02.09.0314H
Device Lot Number172042
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2018
Initial Report FDA Received Date04/19/2018
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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