MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL COMPONENT

Model Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 september 2020: lot 157715: (b)(4) items manufactured and released on 18-mar-2016.Expiration date: 2021-02-02.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.Additional items involved in the event, batch review performed on 30 september 2020: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.160022 lot 160022: (b)(4) items manufactured and released on 18-mar-2016.Expiration date: 2021-03-03.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.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.160952: lot 160952: (b)(4) items manufactured and released on 13-may-2016.Expiration date: 2021-04-21.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 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.160051: lot 160051: (b)(4) items manufactured and released on 20-apr-2016.Expiration date: 2021-04-03.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.
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted a gmk-sphere femur and insert to act as a spacer 4 years and 2 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10718022
• Report Number: 3005180920-2020-00735
• Device Sequence Number: 16922051
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 10/22/2020

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: 02/02/2021
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 157715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/22/2020
• 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