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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 1/17MM

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MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/17MM Back to Search Results
Model Number 02.09.0117H
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2020
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 28 may 2020: lot 124929ar: (b)(4) items manufactured and released on 11-mar-2014. Expiration date: 2017-10-31. 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 since 1-1-2016. Clinical evaluation performed by medical affairs director: 3. 5 years after knee revision, the patient feels instability and it is found that the knee has acquired laxity and the insert locking screw is broken. Surgery is therefore undertaken to replace the insert with a thicker one (from 17 to 23 mm) and the locking screw is also replaced. The metal components were found to be very solid and therefore left in place. We don't know if the root cause for revision was the finding of a broken screw or the need for additional stability, to be sought with a thicker insert. It is unclear if the broken screw remained in situ or not; we couldn't locate it on the xray. According to report, there was no damage to the main components. Preliminary investigation performed by r&d project manager. Preliminary investigation based on the pictures in our hand. 3. 5 years after knee revision surgery, the patient complaints instability and it is found that the knee has acquired laxity and the insert locking screw is broken. The inlay screw broke in its threaded shaft, at the level of the cantilevered portion of the screw when fixed in the baseplate. Cause for screw breakage remains unknown, we can only suppose that progressive instability could have led unpredictable loads acticting on the joint and early failure of the device. The revision surgery is therefore undertaken to replace the insert with a thicker one (from 17 to 23 mm) and the locking screw is also replaced. At the time of the surgery, both tibial tray and femoral component were found to be solid and therefore left in place. We don't know if the root cause for revision was the finding of a broken screw or the need for additional stability, to be replaced with a thicker insert. According to report, there were no damage to the main components.
 
Event Description
The patient complained knee instability. 3 years and 4 moths after primary surgery the surgeon revised the patient knee finding the inlay screw broken (liner fixation screw). Only the liner was swapped during the surgery. The surgery was completed successfully.
 
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Brand NameGMK-HINGE FIXED TIBIAL INSERT SIZE 1/17MM
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 Key10161717
MDR Text Key195902936
Report Number3005180920-2020-00337
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSZ
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 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model Number02.09.0117H
Device Catalogue Number02.09.0117H
Device Lot Number124929AR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/11/2014
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: 06/17/2020 Patient Sequence Number: 1
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