MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS; KNEE TIBIAL INSERT E-CROSS

Model Number	02.12.E0413FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-aug-2022 on lot 2012397: lot 2012397: (b)(4) items manufactured and released on 01-feb-2021.Expiration date: 2026-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional implanted components: batch review performed on 18-aug-2022 on gmk-sphere 02.12.Ka15r femoral component spherika cemented s5+r (k211004) lot.2113677.Lot 2113677: (b)(4) items manufactured and released on 03-nov-2021.Expiration date: 2026-10-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Batch review performed on 18-aug-2022 on gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.2111929.Lot 2111929: (b)(4) items manufactured and released on 24-nov-2021.Expiration date: 2026-11-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Batch review performed on 18-aug-2022 on gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot.2112781.Lot 2112781: (b)(4) items manufactured and released on 10-dec-2021.Expiration date: 2026-11-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At 4 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS
• Common Device Name: KNEE TIBIAL INSERT E-CROSS
• 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: 15258797
• Report Number: 3005180920-2022-00620
• Device Sequence Number: 12430264
• Product Code: JWH
• UDI-Device Identifier: 07630971261884
• UDI-Public: 07630971261884
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/19/2022

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: 01/14/2026
• Device Model Number: 02.12.E0413FR
• Device Catalogue Number: 02.12.E0413FR
• Device Lot Number: 2012397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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: Male