MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERIKA CEMENTED S3+L; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.12.KA13L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2203798: (b)(4) items manufactured and released on 04-may-2022.Expiration date: 2027-04-22.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 involved implants: batch review performed on (b)(6) 2023 on gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot.2204656.Lot 2204656: (b)(4) items manufactured and released on 15-july-2022.Expiration date: 2027-06-27.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 (b)(6) 2023 on gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot.2202692.Lot 2202692: (b)(4) items manufactured and released on 02-may-2022.Expiration date: 2027-04-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Batch review performed on (b)(6) 2023 on gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.2209500.Lot 2209500: (b)(4) items manufactured and released on 06-july-2022.Expiration date: 2027-06-19.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 FEMORAL COMPONENT SPHERIKA CEMENTED S3+L
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16417238
• Report Number: 3005180920-2023-00097
• Device Sequence Number: 5379073
• Product Code: JWH
• UDI-Device Identifier: 07630345716217
• UDI-Public: 07630345716217
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/22/2023

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 Model Number: 02.12.KA13L
• Device Catalogue Number: 02.12.KA13L
• Device Lot Number: 2203798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/22/2023
• 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 Sex: Female