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	Pain (1994)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 april 2022: lot 173641: (b)(4) items manufactured and released on 11-oct-2017.Expiration date: 2022-09-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Additional device involved.Batch review performed on 22 april 2022: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot.175637: lot 175637: (b)(4) items manufactured and released on 04-jan-2018.Expiration date: 2022-12-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 4 years after the primary, the patient came in reporting pain and the surgeon observed that the components were loose and the cause is unknown.The surgeon revised all components and 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: 14346312
• Report Number: 3005180920-2022-00352
• Device Sequence Number: 5270113
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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): 05/10/2022

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: 09/26/2022
• Device Model Number: 02.12.0004R
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 173641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2017
• 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