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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 1/20MM
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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM Back to Search Results
Model Number 02.09.0120H
Health Effect - Clinical Code Bacterial Infection (1735)
Date of Event 11/13/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 november 2020 lot 161838: (b)(4) items manufactured and released on 12-apr-2016.Expiration date: 28.Mar.2021.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
Washout out and ploy swap almost 2 months after primary since the wound did not heal.Infection was confirmed, the pathogen was strep oralis and strep mitis.The surgery was completed successfully.
 
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Brand Name
GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM
Common Device Name
FIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key10974217
Report Number3005180920-2020-00884
Device Sequence Number3186398
Product Code KRO
UDI-Device Identifier07630030825019
UDI-Public07630030825019
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K130299
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/09/2020
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 Date03/28/2021
Device Model Number02.09.0120H
Device Catalogue Number02.09.0120H
Device Lot Number161838
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/13/2020
Initial Report FDA Received Date12/09/2020
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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