MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.0512SCF FIXED TIBIAL INSERT SC SIZE 5/12MM; KNEE FIXED TIBIAL INSERT

Model Number	02.07.0512SCF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came to see the surgeon after taking a blood thinner.It was observed that the patient needed a synovectomy as a result.At about 5 years and 3 months from primary the surgeon performed a synovectomy and revised the liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 december 2022: lot 165098: (b)(4)items manufactured and released on 20-oct-2016.Expiration date: 2021-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-REVISION 02.07.0512SCF FIXED TIBIAL INSERT SC SIZE 5/12MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16015098
• Report Number: 3005180920-2022-00960
• Device Sequence Number: 17998686
• Product Code: JWH
• UDI-Device Identifier: 07630030818332
• UDI-Public: 07630030818332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 12/20/2022

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: 10/15/2021
• Device Model Number: 02.07.0512SCF
• Device Catalogue Number: 02.07.0512SCF
• Device Lot Number: 165098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male