MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMUR SPHERE CEMENTED RIGHT SIZE 4

Model Number	02.12.0004R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 november 2024: lot 2246097: 103 items manufactured and released on 28-feb-2023.Expiration date: 2028-02-08.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.Additional components involved and revised: gmk-sphere 02.12.E0410crr tibial insert fixed sphere cr size 4/10 mm r (k202022) lot 2116995: (b)(4) manufactured and released on 12-jan-2022.Expiration date: 2026-12-19.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.T3i4r tibial tray fixed cemented size t3i4 r (k121416) lot 2242813: (b)(4) manufactured and released on 17-feb-2023.Expiration date: 2028-02-01.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.Conclusions: 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.
Event or Problem Description
Revision due to of infection at about 1 year and 6 months post primary.The pathogen is unknown.The surgeon revised all medacta hardware and implanted permanent product.The surgery was completed successfully.
Additional Manufacturer Narrative
Receiving the complaint related to mdr (b)(4) that is associated to this complaint (mdr (b)(4)) the patient's information gender and date of birth were reported.The complaint related to mdr (b)(4) was reported on november 23rd 2024.The section a2 and a3a were updated.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMUR SPHERE CEMENTED RIGHT SIZE 4
• 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: 20735104
• Report Number: 3005180920-2024-00972
• Device Sequence Number: 18331888
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 12/09/2024

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 Model Number: 02.12.0004R
• Device Lot Number: 2246097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Age: 68 YR
• Patient Sex: Female