MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

Model Number	02.12.0512FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 may 2020: lot 179667: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional items involved in the event, batch review performed on 12 may 2020: gmk-sphere 02.12.0026l femoral component sphere cemented size 6+ l (k140826) lot.1901878 lot 1901878: (b)(4) items manufactured and released on 02-jul-2019.Expiration date: 2024-06-22.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.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.1905242 lot 1905242: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Event or Problem Description
The patient came in, three months after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon removed all implants and performed a washout.A femoral and tibial component were implanted along with antibiotic cement.The surgeon will implant permanent hardware at a later date that has yet to be determined.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10117916
• Report Number: 3005180920-2020-00306
• Device Sequence Number: 2116567
• Product Code: JWH
• UDI-Device Identifier: 07630030826771
• UDI-Public: 07630030826771
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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: 03/14/2023
• Device Model Number: 02.12.0512FL
• Device Catalogue Number: 02.12.0512FL
• Device Lot Number: 179667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 06/04/2020
• 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: 70 YR