MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL AUGMENTATION SIZE 1/10MM; KNEE TIBIAL AUGMENTATION

Catalog Number	02.09.TA110
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 april 2019: lot 170524: (b)(4) items manufactured and released on 20-mar-2017.Expiration date: 2022-03-06.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 by washing and (b)(4): as visible in the pictures provided of the retrieved item, the primary sterility packaging of the implants 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 or Problem Description
During the primary surgery has been noticed that the second packaging of the implant was damaged (unsealed blister, the first packaging wasn't damaged).The surgeon decided to use another implant.The surgery was completed successfully.

• Brand Name: GMK-REVISION TIBIAL AUGMENTATION SIZE 1/10MM
• Common Device Name: KNEE TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8527551
• Report Number: 3005180920-2019-00295
• Device Sequence Number: 19268599
• Product Code: KRO
• UDI-Device Identifier: 07630030825668
• UDI-Public: 07630030825668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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: 03/06/2022
• Device Catalogue Number: 02.09.TA110
• Device Lot Number: 170524
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/18/2019
• 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