MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R; KNEE FIXED INLAY

Model Number	02.12.0414FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-sept-2021: lot 179698: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-apr-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional items involved in the event, batch review performed on 02-sept-2021: gmk-sphere 02.12.0005r femoral component sphere cemented size 5 r (k121416) lot.1906036.Lot 1906036: (b)(4) items manufactured and released on 29-oct-2019.Expiration date: 2024-oct-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.1908636.Lot 1908636: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-dec-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in due to signs of infection and the pathogen was unknown.The surgeon performed an i&d and poly swap and the surgery was completed successfully.Complaint (b)(4) was filed.Presently, on (b)(6) 2021, 8 months after the previous surgery, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R
• Common Device Name: KNEE FIXED INLAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12545490
• Report Number: 3005180920-2021-00777
• Device Sequence Number: 17121878
• Product Code: JWH
• UDI-Device Identifier: 07630030826627
• UDI-Public: 07630030826627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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: 04/05/2023
• Device Model Number: 02.12.0414FR
• Device Catalogue Number: 02.12.0414FR
• Device Lot Number: 179698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/29/2021
• 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: 60 YR