MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM

Model Number	02.12.0312FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 january 2022.Lot 186015: (b)(4) items manufactured and released on 08-nov-2018.Expiration date: 2023-oct-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.Additional items involved in the event, batch review performed on 25 january 2022: gmk-sphere 02.12.0003l femoral component sphere cemented size 3 (k121416) l lot.2000468 lot 2000468: (b)(4) items manufactured and released on 15-apr-2020.Expiration date: 2025-apr-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.1908619.Lot 1908619: (b)(4) items manufactured and released on 06-apr-2020.Expiration date: 2025-mar-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Gmk-sphere 02.07.0033rp patella resurfacing size 1 (k090988) lot.2000625.Lot 2000625: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 1 year and 4 months after the primary surgery, the surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM
• Common Device Name: TIBIAL INSERT FIXED
• 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: 13547747
• Report Number: 3005180920-2022-00106
• Device Sequence Number: 5199379
• Product Code: JWH
• UDI-Device Identifier: 07630030826375
• UDI-Public: 07630030826375
• 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: 2022
• 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): 02/17/2022

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: 10/22/2023
• Device Model Number: 02.12.0312FL
• Device Catalogue Number: 02.12.0312FL
• Device Lot Number: 186015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2018
• 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: Female