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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 4/26MM KNEE TIBIAL INSERT FIXED

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM KNEE TIBIAL INSERT FIXED Back to Search Results
Catalog Number 02.09.0426H
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 6 november 2019: lot 135270: (b)(4) items manufactured and released on 27-feb-2014. Expiration date: 2018-11-30. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold with one similar reported event.
 
Event Description
Second revision surgery 1 year and 9 months after the previous revision due to the tibial screw breakage. Entire prosthesis has been revised.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 4/26MM
Type of DeviceKNEE TIBIAL INSERT FIXED
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 Key9665173
MDR Text Key177770533
Report Number3005180920-2020-00034
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAS
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2018
Device Catalogue Number02.09.0426H
Device Lot Number135270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/27/2014
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: 02/04/2020 Patient Sequence Number: 1
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