MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0022R
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 march 2022: lot 172753: (b)(4) items manufactured and released on 10-sept-2017.Expiration date: 2022-09-03.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-1-2018.Other devices involved: batch review performed on 24 march 2022: gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 171951: (b)(4) items manufactured and released on 24-july-2017.Expiration date: 2022-07-06.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-1-2018.Gmk-sphere 02.12.0211fr tibial insert fixed sphere flex #2/11 mm r (k140826) lot 164442: (b)(4) items manufactured and released on 19-oct-2016.Expiration date: 2021-09-19.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since 1-1-2018.
Event or Problem Description
At 3 years and 11 months post primary revision surgery for knee instability.The reason of instability is unknown.All components have been revised successfully.

• Brand Name: GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• 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: 14101037
• Report Number: 3005180920-2022-00250
• Device Sequence Number: 6229417
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• 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: 2018
• Device Explanted Year: 2022
• 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): 04/13/2022

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: 09/03/2022
• Device Model Number: 02.12.0022R
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 172753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2017
• 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