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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 4/12MM

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM Back to Search Results
Catalog Number 02.09.0412H
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hematoma (1884)
Event Date 09/24/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 2 october 2019: lot 189415: (b)(4) items manufactured and released on 22-gen-2019. Expiration date: 2024-01-03. 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
Revision surgery performed 18 days after the primary due to pain due to a hematoma in the knee. The cause of the hematoma is unknown. The surgeon performed a washout and inlay swap successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM
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 Key9232329
MDR Text Key173184441
Report Number3005180920-2019-00895
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 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number02.09.0412H
Device Lot Number189415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2019
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: 10/24/2019 Patient Sequence Number: 1
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