MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM R

Model Number	02.12.0312FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 march 2020: lot 186065: (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-12-03.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.Other devices involved in the event: gmk-sphere 02.12.0003r femoral component sphere cemented # 3 r lot.165052 (k121416).Batch review performed on 06 march 2020: lot 165052: (b)(4) items manufactured and released on 11-oct-2016.Expiration date: 2021-09-28.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.Gmk-sphere 02.07.0034rp patella resurfacing # 2 lot.165518 (k090988).Batch review performed on 06 march 2020: lot 165518: (b)(4) items manufactured and released on 21-nov-2016.Expiration date: 2021-11-07.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.T4i3r tibial tray fixed cemented # t4-i3 r lot.163353 (k121416).Batch review performed on 06 march 2020: lot 163353: (b)(4) items manufactured and released on 26-jul-2016.Expiration date: 2021-06-13.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.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2017.On (b)(6) 2019, the poly was revised because of an infection.Presently, on (b)(6) 2020, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and removed all hardware and proceeded to implant an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM R
• Common Device Name: TIBIAL INSERT FIXED FLEX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9909609
• Report Number: 3005180920-2020-00207
• Device Sequence Number: 3272135
• Product Code: JWH
• UDI-Device Identifier: 07630030826382
• UDI-Public: 07630030826382
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

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: No Information
• Device Expiration Date: 12/03/2023
• Device Model Number: 02.12.0312FR
• Device Catalogue Number: 02.12.0312FR
• Device Lot Number: 186065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 04/01/2020
• 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