MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM

Model Number	02.07.0414PSF
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-dec-2020: lot 175282: (b)(4) items manufactured and released on 14-aug-2017.Expiration date: 20-jul-2022.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.
Event or Problem Description
The patient had primary knee surgery and was implanted with competitor components.On (b)(6) 2020, the patient came in for reasons unknown and had the competitor implants revised with medacta.During the revision knee surgery, while the surgeon was implanting the final insert implant, the screw broke.The surgeon was not able to extract the broken threads and ended up cementing the bearing into the tibial tray to complete the case.There was no delay in the surgery and a consignment set was utilized.The surgery was completed successfully.A 6 nm screwdriver has been used.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/14MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11043171
• Report Number: 3005180920-2020-00938
• Device Sequence Number: 2692440
• Product Code: JWH
• UDI-Device Identifier: 07630030817847
• UDI-Public: 07630030817847
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/20/2020

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: 07/20/2022
• Device Model Number: 02.07.0414PSF
• Device Catalogue Number: 02.07.0414PSF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/20/2020
• 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