MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R; KNEE FEMORAL COMPONENT

Model Number	02.12.0004R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022, lot 2012008: lot 2012008: 80 items manufactured and released on (b)(6) 2021.Expiration date: 2025-dec-17.No anomalies found related to the problem.To date, 73 items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved: batch review performed on (b)(6) 2022 gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416), lot 2012086: lot 2012086: 87 items manufactured and released on 12-may-2021.Expiration date: 2026-apr-28.No anomalies found related to the problem.To date, 71 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on (b)(6) 2022 gmk-sphere 02.12.0412fr tibial insert fixed sphere flex size 4/12 mm r (k121416), lot 2009032: lot 2009032: 75 items manufactured and released on 10-nov-2020.Expiration date: 2025-oct-11.No anomalies found related to the problem.To date, 42 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 6 months after the primary surgery, the surgeon performed a washout and revised all components.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14998485
• Report Number: 3005180920-2022-00518
• Device Sequence Number: 19303084
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 07/13/2022

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: 12/17/2025
• Device Model Number: 02.12.0004R
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 2012008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female