MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM; KNEE TIBIAL INSERT

Catalog Number	02.07.0226SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 october 2019.Lot 183188: (b)(4) items manufactured and released on 19-jun-2018.Expiration date: 2023-06-06.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery and was implanted with all competitor products.The date of the primary surgery is unknown.Subsequently, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon removed all primary implants and implanted an antibiotic spacer.The surgery was completed successfully.On (b)(6) 2019, the patient came in to have permanent hardware implanted.The surgeon implanted the patient with all medacta revision implants.Presently, on (b)(6) 2019, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly-insert, 2 weeks after primary surgery.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/26MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9309055
• Report Number: 3005180920-2019-00949
• Device Sequence Number: 10902773
• Product Code: JWH
• UDI-Device Identifier: 07630030816987
• UDI-Public: 07630030816987
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: 06/06/2023
• Device Catalogue Number: 02.07.0226SCF
• Device Lot Number: 183188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/12/2019
• 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