MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.12.T3I4L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 may 2022: lot 1909440: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2025-03-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by r&d manager: revision surgery of a gmk sphere implant after 1 year and a half from primary due to infection.Pictures of the explanted components have been sent for analysis.No elements relevant for the event can be noted on the explanted components.Causes for infection could have been most likely related to factors not related to the implant.Other devices involved: batch review performed on 13 may 2022: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 2003006: (b)(4) items manufactured and released on 18-june-2020.Expiration date: 2025-05-21.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 02.12.0025l femoral component sphere cemented size 5+ l (k140826) lot 2003217: (b)(4) items manufactured and released on 15-july-2020.Expiration date: 2025-07-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 2005226: (b)(4) items manufactured and released on 22-july-2020.Expiration date: 2025-07-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.
Event or Problem Description
Revision surgery for knee infection at 1 year and 5 months after primary.All components revised successfully.

• Brand Name: GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 14621593
• Report Number: 3005180920-2022-00430
• Device Sequence Number: 5937592
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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: 03/12/2020
• Device Model Number: 02.12.T3I4L
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 1909440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2020
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG