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

Model Number	02.12.0513FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 november 2020: lot 164458: (b)(4) items manufactured and released on 05-oct-2016.Expiration date: 2021-09-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional device involved: batch review performed on 19 november 2020: gmk-sphere 02.12.0026r femoral component sphere cemented size 6+ r (k140826) lot 184867: (b)(4) items manufactured and released on 10-sep-2018.Expiration date: 2023-08-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 184114: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 184114: (b)(4) items manufactured and released on 02-oct-2018.Expiration date: 2023-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot 1904316: (b)(4) items manufactured and released on 05-sep-2019.Expiration date: 2024-08-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.
Event or Problem Description
The patient came in, 6 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10926402
• Report Number: 3005180920-2020-00875
• Device Sequence Number: 716144
• Product Code: JWH
• UDI-Device Identifier: 07630030862670
• UDI-Public: 07630030862670
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 02.12.0513FR
• Device Catalogue Number: 02.12.0513FR
• Device Lot Number: 164458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/01/2020
• 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