MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R; KNEE FIXED TIBIAL INSERT

Model Number	02.12.0312FR
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25.May.2021: lot 2009019: (b)(4) items manufactured and released on 12-nov-2020.Expiration date: 2025-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: gmk-sphere 02.12.0023r femoral component sphere cemented size 3+ r (k140826) lot.2010184.Batch review performed on 25.May.2021: lot 2010184: (b)(4) items manufactured and released on 18-jan-2021.Expiration date: 2026-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: few hours after primary cemented tka with a medially stabilized device, the patient dislocates anteriorly.The devices are then exchanged to a semiconstrained version.The cause of this event is most probably due to insufficient ligament stability of the knee; there is no reason to suspect a device malfunction, nor was it reported.
Event or Problem Description
After the primary knee surgery (the same day), in post-op recovery, it was observed that the patient dislocated anteriorly from the tibia (femur from insert).The cause of the dislocation is unknown.The surgeon revised the femoral component and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11899533
• Report Number: 3005180920-2021-00436
• Device Sequence Number: 13776871
• Product Code: JWH
• UDI-Device Identifier: 07630030826382
• UDI-Public: 07630030826382
• 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: 2021
• 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): 05/28/2021

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: 10/25/2025
• Device Model Number: 02.12.0312FR
• Device Catalogue Number: 02.12.0312FR
• Device Lot Number: 2009019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/28/2021
• 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