MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

Model Number	02.12.T3I4R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20.05.2021: lot 168377: (b)(4) items manufactured and released on 28-mar-2017.Expiration date: 2022-03-19.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 20.05.2021: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.170327 lot 170327: (b)(4) items manufactured and released on 11-apr-2017.Expiration date: 2022-03-23.No anomalies found related to the problem.To date, all items of the same lot have been already sold with 1 similar reported event.Gmk-sphere 02.12.0004r femoral component sphere cemented size 4 r (k121416) lot.168736 lot 168736: (b)(4) items manufactured and released on 5-may-2017.Expiration date: 2022-04-20.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
3 years and 9 months after the primary surgery first stage revision total knee was done due to diagnosed (b)(6) infection 4 years after the primary procedure.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
• Common Device Name: TIBIAL TRAY FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11973432
• Report Number: 3005180920-2021-00472
• Device Sequence Number: 11027582
• Product Code: JWH
• UDI-Device Identifier: 07630030827143
• UDI-Public: 07630030827143
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: 03/19/2022
• Device Model Number: 02.12.T3I4R
• Device Catalogue Number: 02.12.T3I4R
• Device Lot Number: 168377
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/10/2021
• 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: 81 YR
• Patient Weight: 95