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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 5/23MM
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/23MM Back to Search Results
Catalog Number 02.09.0523H
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2018.Lot 144143: 3 items manufactured and released on 06 june 2014.Expiration date: 2019-04-30 no anomalies found related to the problem.To date, 2 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
About 1 month after primary the surgeon revised the patient for an infection.Liner swap.The surgery was completed successfully.(pathogen is not available).
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 5/23MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7905425
Report Number3005180920-2018-00728
Device Sequence Number19203505
Product Code KRO
UDI-Device Identifier07630030825309
UDI-Public07630030825309
Combination Product (Y/N)N
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 other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/25/2018
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 Date04/30/2019
Device Catalogue Number02.09.0523H
Device Lot Number144143
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/29/2018
Initial Report FDA Received Date09/25/2018
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;
Patient Age70 YR
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