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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM KNEE FEMURAL AUGMENTATION

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MEDACTA INTERNATIONAL SA GMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM KNEE FEMURAL AUGMENTATION Back to Search Results
Catalog Number 02.07.220FDA
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 02 jul 2019: 2 device of lot 161346 involved in this complaint: (b)(4) items manufactured and released on 24-oct-2016. Expiration date: 20-04-2021. 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. Two items are present in this complaint with the same lot number. Visual inspection performed by medacta washing & packaging manager: the two items received (femoral augmentation distal) were visually inspected on july 23rd 2019. The event has been confirmed. The packaging of one item was completely opened while the second item packaging was still closed (primary and secondary sterile barrier). Both items presented, into the primary packaging, some white parts of debris probably came from the primary tyvek that was damaged due to the contact with screw and augment. In addition, the primary plastic blister was scratched and in only one item also broken at the corner, these probably due to extreme shipping and handling conditions. The root cause likely relates to the combined factors of anomalous shipping/handling conditions. This is the first event reported on femoral augmentation; no action is at the moment foreseen.
 
Event Description
During the primary knee surgery, the surgeon observed a foreign substance on 2 of the femoral distal augments and chose not to implant them in the patient. There was no delay in the case and the surgeon used another augment to complete the case. The surgery was completed successfully. The same lot (2 items) has been used to complete the surgery.
 
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Brand NameGMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM
Type of DeviceKNEE FEMURAL AUGMENTATION
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 Key8826046
MDR Text Key216377357
Report Number3005180920-2019-00605
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/20/2021
Device Catalogue Number02.07.220FDA
Device Lot Number161346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2016
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: 07/25/2019 Patient Sequence Number: 1
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