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

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.

• Brand Name: GMK-REVISION FEMORAL AUGMENTATION DISTAL SIZE 2/20MM
• Type of Device: KNEE 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 Key: 8826046
• MDR Text Key: 216377357
• Report Number: 3005180920-2019-00605
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030888892
• UDI-Public: 07630030888892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163311
• Number of Events Reported: 1
• 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 Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Catalogue Number: 02.07.220FDA
• Device Lot Number: 161346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other