MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

Model Number	02.12.0005L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the patient had knee primary surgery.On (b)(6) 2023, the patient had an additional surgery performed due to inlay locking screw unscrewing (left knee).The inlay locking screw was removed arthroscopically.On (b)(6) 2023, the patient underwent revision surgery of the left knee due to infection.Only the liner was revised.On (b)(6) 2023, the patient underwent a total knee revision surgery due to infection.The exact date of the surgery, the hospital, and the surgeon are unknown.
Additional Manufacturer Narrative
Batch review performed on 11 febr 2025 (b)(4) items manufactured and released on 15-oct-2015.Expiration date: 2020-09-29.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: revised on 16th february 2023 gmk-sphere 02.12.0410fl tibial insert fixed sphere flex #4/10 mm l (k121416) lot.155642 batch review performed on 11 febr 2025 (b)(4) items manufactured and released on 22-dec-2015.Expiration date: 2020-12-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Revised in (b)(6) 2023: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot.2206647 batch review performed on 11 febr 2025 (b)(4) items manufactured and released on 01-jun-2022.Expiration date: 2027-05-12.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.154444 batch review performed on 11 febr 2025 (b)(4) items manufactured and released on 25-nov-2015.Expiration date: 2020-11-09.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: 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: FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 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: 21458564
• Report Number: 3005180920-2025-00140
• Device Sequence Number: 7591454
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/25/2025

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 Expiration Date: 09/29/2020
• Device Model Number: 02.12.0005L
• Device Lot Number: 154699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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