MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L; KNEE TIBIAL INSERT

Catalog Number	02.12.0025L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for infection at 1 year and 11 months post primary and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 september 2023: lot 2010190: (b)(4) items manufactured and released on 17-dec-2020.Expiration date: 2025-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional components involved in the event: batch review performed on 18 september 2023: gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416) lot.2010601: (b)(4) items manufactured and released on 29-oct-2020.Expiration date: 2025-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other 2 similar reported event in the period of review.Batch review performed on 18 september 2023: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.2103807: (b)(4) items manufactured and released on 16-june-2021.Expiration date: 2026-06-01.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
• Common Device Name: KNEE TIBIAL INSERT
• 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: 17852274
• Report Number: 3005180920-2023-00770
• Device Sequence Number: 6759694
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 10/02/2023

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: 12/09/2025
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 2010190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2020
• 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 Sex: Unknown