MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TRIAL FEMORAL COMPONENT S4 - RIGHT; INSTRUMENT FOR KNEE SURGERY

Model Number	02.12.10.0008
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device involved: gmk-sphere 02.12.10.0112 trial tibial insert flex s4r - 10 mm lot.Unknown.For both devices involved it is not possible to perform a document review since the lot numbers are not available.
Event or Problem Description
During the primary knee surgery, while the surgeon was trialing the femur, tibia and insert, he observed that the trials were a tight fit.The surgeon kept pushing the trial tibia with the insert on it, and ended up cracking the patient's femur medially.In order to complete the case, the surgeon had to use a screw to secure the femur.There was a 15-minute delay in the case and the surgery was completed successfully.A consignment set was utilized.

• Brand Name: GMK-SPHERE TRIAL FEMORAL COMPONENT S4 - RIGHT
• Common Device Name: INSTRUMENT FOR KNEE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10949698
• Report Number: 3005180920-2020-00864
• Device Sequence Number: 2419309
• Product Code: LXH
• UDI-Device Identifier: 07630971201996
• UDI-Public: 07630971201996
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/04/2020

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 Model Number: 02.12.10.0008
• Device Catalogue Number: 02.12.10.0008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/04/2020
• 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