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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 5/14MM KNEE TIBIAL INSERT

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.09.0514H
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hematoma (1884)
Event Date 03/08/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 01 april 2019: lot 182057: (b)(4) items manufactured and released on 26-jun-2018. Expiration date: 2023-06-05. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event Description
The patient came in complaining of pain caused by a hematoma 8 days after primary. The surgeon performed a washout and poly swap and the surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM
Type of DeviceKNEE TIBIAL INSERT
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key8482795
MDR Text Key140908800
Report Number3005180920-2019-00246
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
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 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number02.09.0514H
Device Lot Number182057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/26/2018
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: 04/04/2019 Patient Sequence Number: 1
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