MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

Model Number	02.12.0024L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision performed due to infection about 1 year and 3 months after the primary surgery.All components revised and hinge system implanted.
Additional Manufacturer Narrative
Batch review performed on 14 january 2025: lot 2308294: (b)(4) items manufactured and released on 05-jul-23.Expiration date: 2028-jun-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: batch reviews performed on 14 january 2025.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2311079: (b)(4) items manufactured and released on 29-aug-23.Expiration date: 2028-aug-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0514fl tibial insert fixed sphere flex size 5/14 mm l (k121416) lot 2202782: (b)(4) items manufactured and released on 11-may-2022.Expiration date: 2027-apr-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affaris director: one year after primary cemented tka, a late infection develops and revision is undertaken.The report does mention infection, but the germ is still unknown.Infections are a possible adverse event following total joint replacement, widely described in literature.No reason to suspect that a defective implant is at the origin of this event.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• 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: 21320669
• Report Number: 3005180920-2025-00018
• Device Sequence Number: 7918474
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 02.12.0024L
• Device Lot Number: 2308294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White