MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0210FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hold for kp 3.15 the patient came in reporting pain and the cause is unknown.The surgeon revised all components and revised them with competitor components 2 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 1905117: (b)(4).Expiration date: 2024-09-01.No anomalies found related to the problem.To date, (b)(4).Additional devices involved: batch reviews performed on 18 february 2022: gmk-sphere 02.12.0002r femoral component sphere cemented size 2 (k121416) lot 171814: (b)(4).Expiration date: 2022-06-26.No anomalies found related to the problem.To date, (b)(4).Gmk-sphere 02.07.1202r tibial tray fixed cemented size 2 r (k090988) lot 2011075: (b)(4).Expiration date: 2026-02-28.No anomalies found related to the problem.To date, (b)(4).

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 13769980
• Report Number: 3005180920-2022-00179
• Device Sequence Number: 4104572
• Product Code: JWH
• UDI-Device Identifier: 07630030826146
• UDI-Public: 07630030826146
• 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: 2021
• 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): 03/15/2022

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: 09/01/2024
• Device Model Number: 02.12.0210FR
• Device Catalogue Number: 02.12.0210FR
• Device Lot Number: 1905117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2019
• 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