MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL AUGMENTATION SIZE 3/10MM

Catalog Number 02.09.TA310

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

Batch reviews performed on 19 july 2017.Lot 123245a: (b)(4) items manufactured and released on 16 june 2014.Expiration date: 2019-05-31.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.Gmk-revision femoral wedge posterior size 3/10mm, code 02.07.310fpw, lot.135785 (k102437) (b)(4) items manufactured and released on 28 april 2014.Expiration date: 2018-12-31.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.On 19july 2017 the cleaning and packaging manager performed a preliminary investigation based on the available pictures and commented as follows: - wedge: as visible in the attached picture the packaging is damaged.The nature of the damage presents, as visually evident, allowing the surgeon to use another femoral wedge.The inner pouch of this packaging configuration was not sufficient to withstand the anomalous shipping stresses experienced in combination with the weight and geometry of the device.- tibial augmentation: as visible in the attached picture the primary sterility packaging is damaged.It is likely that the handling activities caused aggressive tibial component movement in the primary sterility packaging, causing the breakage of the primary barrier and impacting the secondary sterility blister.

Event Description

When the tibial augment was opened, it was noticed that the internal packaging was punctured.The surgeon believed the sterility was not compromised so he decided to implant the subject tibial augment.Also, the packaging of the posterior femoral wedge found was found torn.The surgeon did not implant the subject posterior femoral wedge as he thought the sterility may be compromised.The surgeon proceeded using a second implant (different size) to complete the case.The surgery was completed successfully.

• Brand Name: GMK-REVISION TIBIAL AUGMENTATION SIZE 3/10MM
• Type of Device: TIBIAL 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, 6874 ; SZ 6874
• MDR Report Key: 6724704
• MDR Text Key: 80561775
• Report Number: 3005180920-2017-00390
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825705
• UDI-Public: 07630030825705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 02.09.TA310
• Device Lot Number: 123245A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2014
• 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
• Patient Age: 65 YR