MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

Model Number	02.12.0025L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 3 march 2021: lot 1900310: (b)(4) items manufactured and released on 24-apr-2019.Expiration date: 2024-04-08.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 3 march 2021: gmk-sphere 02.12.0610fl tibial insert fixed sphere flex size 6/10 mm l (k121416) lot.178750.Lot 178750: (b)(4) items manufactured and released on 6-mar-2018.Expiration date: 2023-02-19.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 02.07.1206l tibial tray fixed cemented size 6 l (k090988) lot.182894.Lot 182894: (b)(4) items manufactured and released on 26-sep-2018.Expiration date: 2023-09-13.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 came in 1 year and 5 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11481956
• Report Number: 3005180920-2021-00217
• Device Sequence Number: 17112972
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 04/08/2024
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 1900310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/15/2021
• 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