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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/13/2020
Event Type  Injury  
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 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 NameGMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM
Type of DeviceFIXED TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key10974217
MDR Text Key220401365
Report Number3005180920-2020-00884
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K130299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2021
Device Model Number02.09.0120H
Device Catalogue Number02.09.0120H
Device Lot Number161838
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2020 Patient Sequence Number: 1
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