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	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 january 2020.Lot 184193: (b)(4) items manufactured and released on 26-sep-2018.Expiration date: 2023-09-11.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 complaint, batch review performed on (b)(6) 2020.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.182891.Lot 182891: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416) lot.183024.Lot 183024: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-07-16.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.Clinical evaluation performed by medical affairs manager: delayed infection in cemented tka, 11 months after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer almost 1 year after primary.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: 9698515
• Report Number: 3005180920-2020-00035
• Device Sequence Number: 11452059
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: 09/11/2023
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 184193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• 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