MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1201L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 3 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 may 2024 lot 2200536: (b)(4) items manufactured and released on 04-may-2022.Expiration date: 2027-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional revised implants batch review performed on 02 may 2024 on gmk-sphere 02.12.0002l femoral component sphere cemented size 2 l (k121416) lot.2101892 lot 2101892: (b)(4) items manufactured and released on 09-apr-2021.Expiration date: 2026-03-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 02 may 2024 on gmk-sphere 02.12.0113fl tibial insert fixed sphere flex size 1/13 mm l (k140826) lot.186001 lot 186001: (b)(4) items manufactured and released on 28-sep-2018.Expiration date: 2023-09-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19381855
• Report Number: 3005180920-2024-00334
• Device Sequence Number: 3770490
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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 Catalogue Number: 02.07.1201L
• Device Lot Number: 2200536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• 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: 86 YR
• Patient Sex: Female
• Patient Race: Asian