MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/12MM

Catalog Number	02.07.0212SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 december 2019: lot 178509: (b)(4) items manufactured and released on 24-jan-2018.Expiration date: 2023-01-10.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.Additional implant involved: gmk-revision 02.07.2403l femur revision ps size 3 l (k102437) lot.164174.Batch review performed on 05 december 2019: lot 164174: (b)(4) items manufactured and released on 12-ago-2016.Expiration date: 2021-07-24.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
About 1 year and 3 months after primary the surgeon revised the patient knee insert and femur for an infection (recidivist infection).The surgery was completed successfully.The pathogen is unknown.Femur implanted on (b)(6) 2018.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/12MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9466929
• Report Number: 3005180920-2019-01069
• Device Sequence Number: 1834197
• Product Code: JWH
• UDI-Device Identifier: 07630030816598
• UDI-Public: 07630030816598
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Expiration Date: 01/10/2023
• Device Catalogue Number: 02.07.0212SCF
• Device Lot Number: 178509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/13/2019
• 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: Required Intervention
• Patient Age: 64 YR