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

Model Number	02.12.0025L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2021: lot 183449: (b)(4) items manufactured and released on 25-july-2018.Expiration date: 2023-07-15.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.Another devices involved: batch review performed on 26 april 2021: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 186201: (b)(4) items manufactured and released on 12-nov-2018.Expiration date: 2023-10-28.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 size 2 (k090988) lot 187397: (b)(4) items manufactured and released on 30-oct-2018.Expiration date: 2023-10-15.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 02.12.0511fl tibial insert fixed sphere flex size 5/11 mm l (k140826) lot 179666: (b)(4) items manufactured and released on 10-apr-2018.Expiration date: 2023-03-21.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.
Event or Problem Description
2 years 3 months after the primary the patient came in due to signs of an infection and the pathogen is escherichia coli.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ L
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11847282
• Report Number: 3005180920-2021-00390
• Device Sequence Number: 3724296
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• 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: 2019
• Device Explanted Year: 2021
• 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): 05/19/2021

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: 07/15/2023
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 183449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• 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