MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0610FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 october 2020: lot 1908781: (b)(4) items manufactured and released on 22-nov-2019.Expiration date: 2024-11-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: early infection in cemented tka, 1 month after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
1 month post operation, the patient returned with signs of periprosthetic joint infection.Diar (debridement, antibiotics and implant retention) has been performed and the liner has been successfully revised.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/10 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10860232
• Report Number: 3005180920-2020-00805
• Device Sequence Number: 11749645
• Product Code: JWH
• UDI-Device Identifier: 07630030826931
• UDI-Public: 07630030826931
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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 Expiration Date: 11/09/2024
• Device Model Number: 02.12.0610FL
• Device Catalogue Number: 02.12.0610FL
• Device Lot Number: 1908781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/18/2020
• 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
• Patient Weight: 100