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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 2/14MM KNEE TIBIAL LINER

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM KNEE TIBIAL LINER Back to Search Results
Catalog Number 02.09.0214H
Device Problems Loose or Intermittent Connection (1371); Unstable (1667)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 03-jan-2020: lot 163644: (b)(4) items manufactured and released on 28-sep-2016. Expiration date: 31. 08. 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. Clinical evaluation performed by medacta medical affairs director: almost 3 years after revision tka with a constrained device, the screw that connects the femoral component to the rotating post is found loose in the joint at xray examination. Surgery is undertaken and the screw is replaced. The insert is also exchanged, out of standard practice in similar circumstances. The reason for the spontaneous back-out of the screw cannot be determined with the information at hand. One possible mechanical explanation is insufficient tightening torque at primary surgery, but other causes may also play a role. No clinical cause for the event can be identified and no further clinical consequences should be expected.
 
Event Description
The patient came in complaining of instability due to a loose gmk hinge post screw 2 years and 9 months after primary. The surgeon was able to remove the screw and he also performed a poly swap. The surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
Type of DeviceKNEE TIBIAL LINER
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 Key9563571
MDR Text Key216652593
Report Number3005180920-2019-01115
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number02.09.0214H
Device Lot Number163644
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/28/2016
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: 01/08/2020 Patient Sequence Number: 1
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