MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / RIGHT; CEMENTED KNEE FEMORAL COMPONENT

Model Number	02.07.2216R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05.Mar.2021: lot 150972a: 1 item manufactured and released on 9-mar-2020.Expiration date: 2025-02-25.No anomalies found related to the problem.To date, 1 item of the same lot have been already sold without any other similar reported event.Additional implant involved: gmk-primary 02.07.0412psf tibial insert ps fixed size 4/12mm (k090988) lot.179573 batch review performed on 05.Mar.2021: lot 179573: 75 items manufactured and released on 20-mar-2018.Expiration date: 2023-03-09.No anomalies found related to the problem.To date, 64 items of the same lot have been already sold without any other similar reported event.Additional implant involved: gmk-primary 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.1909610 batch review performed on 05.Mar.2021: lot 1909610: 132 items manufactured and released on 6-apr-2020.Expiration date: 2025-03-29.No anomalies found related to the problem.To date, 103 items of the same lot have been already sold without any other similar reported event.Additional implant involved: gmk-primary 02.07.0034rp patella resurfacing size 2 (k090988) lot.2000628 batch review performed on 05.Mar.2021: lot 2000628: 240 items manufactured and released on 3-mar-2020.Expiration date: 2025-02-18.No anomalies found related to the problem.To date, 224 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in 4 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-PRIMARY FEMUR CEMENTED PS SIZE 6NARROW / RIGHT
• Common Device Name: CEMENTED KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11548782
• Report Number: 3005180920-2021-00225
• Device Sequence Number: 17126659
• Product Code: JWH
• UDI-Device Identifier: 07630030821035
• UDI-Public: 07630030821035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/23/2021

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: 02/25/2025
• Device Model Number: 02.07.2216R
• Device Catalogue Number: 02.07.2216R
• Device Lot Number: 150972A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/23/2021
• 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
• Patient Age: 85 YR
• Patient Weight: 94