MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ L

Model Number	02.12.0026L
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 25.11.2020: lot#: 183452: 45 items manufactured, and released on 10-jul-2018.Expiration date: 2023-06-27.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l lot.179501 (k090988); batch review performed by medacta regulatory affairs department on 25.11.2020: lot 179501: 100 items manufactured and released on 10-apr-2018.Expiration date: 2023-03-27.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-sphere 02.12.0511fl tibial insert fixed sphere flex size 5/11 mm l lot.177403 (k140826) batch review performed by medacta regulatory affairs department on 25.11.2020: lot 177403: 50 items manufactured and released on 1-mar-2018.Expiration date: 2023-02-9.No anomalies found related to the problem.To date, 37 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 10 months from the primary surgery due to instability.The knee becomes unstable after the therapist manipulated the knee into extension.It appears to be soft-tissue related as pop was felt.The surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10905589
• Report Number: 3005180920-2020-00832
• Device Sequence Number: 19594484
• Product Code: JWH
• UDI-Device Identifier: 07630030862434
• UDI-Public: 07630030862434
• Combination Product (Y/N): Y
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2023
• Device Model Number: 02.12.0026L
• Device Catalogue Number: 02.12.0026L
• Device Lot Number: 183452
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• 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
• Patient Age: 71 YR