MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMORAL WEDGE DISTAL SIZE 4/4MM

Catalog Number	02.07.404FDW
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection done on mar 27, 2018 by packaging and washing manager: the implant was received and the packaging was confirmed to be broken, as it could be seen also from the pictures provided at the moment of the notification.The inner pouch of the packaging configuration applied was not sufficient to withstand the anomalous shipping stresses experienced in combination with the weight and geometry of the device.Batch review performed on 03 april 2018; lot 140513: (b)(4) items manufactured and released on 27 may 2014.Expiration date: 2019-04-30 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.Preliminary investigation performed on 16 march 2018 by (b)(4): form the pictures received it is possible confirmed it was packed with the old version of the packaging (modified due to this issue, already occurred in the past).
Event or Problem Description
The implant was found loose in the blister, outside the inner packaging, after opening the blister.The surgeon used another implant; no critical delay.

• Brand Name: GMK-REVISION FEMORAL WEDGE DISTAL SIZE 4/4MM
• Common Device Name: FEMORAL WEDGE DISTAL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7402535
• Report Number: 3005180920-2018-00211
• Device Sequence Number: 16487355
• Product Code: JWH
• UDI-Device Identifier: 07630030822476
• UDI-Public: 07630030822476
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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: 04/30/2019
• Device Catalogue Number: 02.07.404FDW
• Device Lot Number: 140513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 04/06/2018
• 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