MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TRIAL FEMUR SIZE 4 R

Model Number 02.12.10.0008

Device Problem Fitting Problem (2183)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Pieces and lots are not available for further investigations.Items involved in the event: gmk-sphere 02.12.10.0008 trial femur size 4 r lot.Unknown.Gmk-sphere 02.12.10.0112 trial tibial insert flex s4r - 10 mm lot.Unknown.

Event 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 FEMUR SIZE 4 R
• Type of Device: TRIAL FEMUR
• 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: 10974216
• MDR Text Key: 220418845
• Report Number: 3005180920-2020-00879
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07630971201996
• UDI-Public: 07630971201996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.12.10.0008
• Device Catalogue Number: 02.12.10.0008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention