MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 2 R; CEMENTED FEMUR COMPONENT

Model Number	02.07.2402R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 october 2020 lot 189488: 24 items manufactured and released on 06-mar-2019.Expiration date: 2024-02-26.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any similar reported event.Additional implant involved:gmk-revision 02.07.0682r revision fixed tibial tray cemented size 2 r (k123721) lot.1903716 batch review performed on 20 october 2020 lot 1903716: 11 items manufactured and released on 25-sep-2019.Expiration date: 2024-09-18.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.0220scf fixed tibial insert sc size 2/20mm (k103170) lot.178510 batch review performed on 20 october 2020 lot 178510: 18 items manufactured and released on 02-feb-2018.Expiration date: 2023-01-18.No anomalies found related to the problem.To date, 6 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.Fcl15105 extension stem - fluted ø 15 l 105 (k120790) lot.1900650 batch review performed on 20 october 2020 lot 1900650: 45 items manufactured and released on 05-jun-2019.Expiration date: 2024-05-21.No anomalies found related to the problem.To date, 17 items of the same lot have been already sold with one similar event reported.Additional implant involved: gmk-revision 02.07.Fcl14105 extension stem - fluted ø 14 l 105 (k120790) lot.167136a batch review performed on 20 october 2020 lot 167136a: 1 item manufactured and released on 25-sep-2019.Expiration date: 2024-08-28.No anomalies found related to the problem.To date, 1 item of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of infection, 5 months after primary surgery, and the pathogen is unknown.The surgeon removed all implants and implanted a medacta femur and poly with antibiotic cement to act as a spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 2 R
• Common Device Name: CEMENTED FEMUR COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10821834
• Report Number: 3005180920-2020-00790
• Device Sequence Number: 14187454
• Product Code: JWH
• UDI-Device Identifier: 07630030821394
• UDI-Public: 07630030821394
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 02/26/2024
• Device Model Number: 02.07.2402R
• Device Catalogue Number: 02.07.2402R
• Device Lot Number: 189488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/11/2020
• 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