MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION SC TIBIAL FIXED LINER; FIXED PE TIBIAL INSERT

Catalog Number	02.07.0410SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional info received on the 7th november 2017: the revision was completed due to the infection.Only the liner was changed.Unfortunately the pathogen is unknown at this time.Batch review performed on 30 november 2017.Lot 122367: (b)(4) items manufactured and released on 19-dec-2012.Expiration date: 2017-08-31.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.
Event or Problem Description
Following the visual presence of an infection the knee was washed out several time as a precaution.After the final washout the poly liner was swapped out for a new one.

• Brand Name: GMK REVISION SC TIBIAL FIXED LINER
• Common Device Name: FIXED PE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7074504
• Report Number: 3005180920-2017-00718
• Device Sequence Number: 939687
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02.07.0410SCF
• Device Lot Number: 122367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 100