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

Catalog Number	02.07.220FDA
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: KNEE FEMURAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8826046
• Report Number: 3005180920-2019-00605
• Device Sequence Number: 16832930
• Product Code: KRO
• UDI-Device Identifier: 07630030888892
• UDI-Public: 07630030888892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other