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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 4/23MM KNEE TIBIAL INSERT

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM KNEE TIBIAL INSERT Back to Search Results
Catalog Number 02.09.0423H
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on "2410" september 2019. Lot 143831: (b)(4) items manufactured and released on 22-sept-2014. Expiration date: 2019-07-30. No anomalies found related to the problem. To date, (b)(4) item of the same lot has been already sold without any similar reported event. Clinical evaluation performed by medical affairs director two years after revision tka with constrained prosthesis the screw holding the pe insert is found to be broken, although the insert is regularly in place. Surgery is performed to replace the polyethylene component. The report does not say whether a new screw could be used. We cannot determine if the screw got broken at surgery or later on. Lack of information does not allow a fully meaningful analysis to be performed. There are no elements that let us understand how and why the screw fractured.
 
Event Description
The patient came in for a follow-up appointment and had x-rays taken. The surgeon observed that the screw that holds the tibial insert to the tibial tray was broken. Two years after primary surgery, the surgeon revised the poly and the broken screw. The patient did not complain of pain or discomfort before the revision surgery. The surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM
Type of DeviceKNEE 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 Key9196343
MDR Text Key173447956
Report Number3005180920-2019-00856
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 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/30/2019
Device Catalogue Number02.09.0423H
Device Lot Number143831
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/22/2014
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: 10/16/2019 Patient Sequence Number: 1
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