MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS; KNEE TIBIAL INSERT

Catalog Number	02.12.E0511FL
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 october 2023: lot 2243417: (b)(4) manufactured and released on 24-jan-2023.Expiration date: 2028-01-01.No anomalies found related to the problem.To date, (b)(4).Additional devices involved implanted on (b)(6) 2023 and explanted on (b)(6) 2023.Batch reviews performed on 12 october 2023.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2237780: (b)(4) manufactured and released on 27-dec-2022.Expiration date: 2027-12-08.No anomalies found related to the problem.To date, (b)(4 of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.0006l femoral component sphere cemented size 6 l (k121416) lot 2245088: (b)(4) manufactured and released on 27-dec-2022.Expiration date: 2028-01-29.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Gmk-sphere 02.12.E004rp patella resurfacing size 4 e-cross (k202022) lot 2238000: (b)(4) manufactured and released on 09-nov-2022.Expiration date: 2027-10-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Investigation performed on the received pictures on 31 october 2023 by medacta knee r&d project manager: revision surgery after 2 weeks from primary due to infection on a patient that was already revised for infection.Pictures of the explanted components doesn't show any anomalies.Infection is an undesired event in knee replacement surgeries that requires revision of implanted components, unlikely caused by the hardware itself.From preliminary investigation, there is no evidence that the event is related to a faulty device.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.Presently, on (b)(6) 2023, 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.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.Revision surgery of a gmk sphere implant after 2 weeks from primary implantation due to infection.No anomalies can be noted of the explanted components sent back for investigation.From visual inspection there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L E-CROSS
• Common Device Name: KNEE TIBIAL INSERT
• 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: 18083935
• Report Number: 3005180920-2023-00859
• Device Sequence Number: 6629606
• Product Code: JWH
• UDI-Device Identifier: 07630971262034
• UDI-Public: 07630971262034
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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 Catalogue Number: 02.12.E0511FL
• Device Lot Number: 2243417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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