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

Model Number	02.12.0004L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the (b)(6) 2022, the patient undergone a primary surgery with implantation of gmk-sphere system.On the (b)(6) 2024, the patient has been revised for infection and the insert has been changed (no information on ref and lot).On the (b)(6) 2024, the patient has been revised because of infection.The surgeon removed all the components, performed a washout and implanted a gmk-revision system.
Additional Manufacturer Narrative
Batch review performed on 08-aug-2024: lot 2009134: (b)(4) items manufactured and released on 06-nov-2020.Expiration date: 2025-10-19.No anomalies found related to the problem.To date, all the 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 08-aug-2024: gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3i4 l (k121416) lot 2106111: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-07-28.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 02.12.0411fl tibial insert fixed sphere flex size 4/11 (k140826) lot 2336415: (b)(4) items manufactured and released on 25-sep-2023.Expiration date: 2028-09-11.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 Manufacturer Narrative
Visual investigation performed by medacta r&d knee project manager: revision surgery for infection after 26 months from primary implantation and 5 months after first revision surgery with a poly swap due to infection.No traces of residual cement can be seen on the tibial tray.Some residual bone can be seen on the internal surface of the femoral component.No loosening has been reported, there is no evidence that poor inter-digitation between cement and implant is an infection-promoting factor.Based on the available information it is not possible to state an implant's related failure root cause.Corrections: d4 reference inserted in the model number field.D1 brand name corrected.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20063780
• Report Number: 3005180920-2024-00681
• Device Sequence Number: 8826501
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 10/19/2025
• Device Model Number: 02.12.0004L
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 2009134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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 Age: 84 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White