MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L

Model Number	02.12.0513FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2020: lot 168321: (b)(4) items manufactured and released on 23-feb-2017.Expiration date: 2022-02-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 18 may 2020: gmk-revision 02.07.0514scf fixed tibial insert sc size 5/14mm (k103170) lot.146769.Lot 146769: (b)(4) items manufactured and released on 29-oct-2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event since 2016.
Event or Problem Description
Patient was implanted in right knee with competitor products.Then revision surgery was performed on the (b)(6) 2016 and revision insert was implanted.Left knee primary surgery was performed on the (b)(6) 2018, sphere insert was used.Now the patient came in due to signs of infection in both knees and the pathogen is unknown.The surgeon performed a bilateral i&d and poly swap and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10147230
• Report Number: 3005180920-2020-00321
• Device Sequence Number: 13976714
• Product Code: JWH
• UDI-Device Identifier: 07630030862656
• UDI-Public: 07630030862656
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 02/07/2022
• Device Model Number: 02.12.0513FL
• Device Catalogue Number: 02.12.0513FL
• Device Lot Number: 168321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/12/2020
• 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: 77 YR