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

Model Number	02.12.0005R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery performed on the (b)(6) 2024.1st revision surgery performed on the (b)(6) 2024.The patient was revised due to infection.Washout and liner revised as per standard procedure.2nd revision surgery performed on the (b)(6) 2024.Explantation of all components due to infection.Placement of a spacer and antibiotic therapy for 6 weeks.Reassessment of the situation in (b)(6) 2025.
Additional Manufacturer Narrative
Batch review performed on 22 december 2024 lot 2412050: (b)(4) items manufactured and released on 03-july-2024.Expiration date: 2029-06-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional implants revised batch review performed on 22 december 2024 on gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.2416675 lot 2416675: (b)(4) items manufactured and released on 23-sep-2024.Expiration date: 2029-09-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Batch review performed on 22 december 2024 on gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot.2414671 lot 2414671: (b)(4) items manufactured and released on 15-july-2024.Expiration date: 2029-06-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Batch review performed on 22 december 2024 on gmk-sphere 02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot.2419050 lot 2419050: (b)(4) items manufactured and released on 03-sep-2024.Expiration date: 2029-08-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.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.
Additional Manufacturer Narrative
Event description updated: primary surgery performed on the (b)(6) 2024.1st revision surgery performed on the (b)(6) 2024.The patient was revised due to infection.Washout and liner revised as per standard procedure.2nd revision surgery performed on the (b)(6) 2024.Explantation of all components due to infection.Placement of a spacer and antibiotic therapy for 6 weeks.On the (b)(6) 2025 antibiotic spacer was removed and gmk-revision system was implanted.
Event or Problem Description
Primary surgery performed on the (b)(6) 2024.1st revision surgery performed on the (b)(6) 2024.The patient was revised due to infection.Washout and liner revised as per standard procedure.2nd revision surgery performed on the (b)(6) 2024.Explantation of all components due to infection.Placement of a spacer and antibiotic therapy for 6 weeks.On the (b)(6) 2025 antibiotic spacer was removed and gmk-revision system was implanted.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE CEMENTED 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: 21026657
• Report Number: 3005180920-2024-01148
• Device Sequence Number: 9022810
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/24/2025

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: 02.12.0005R
• Device Lot Number: 2412050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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: 67 YR
• Patient Sex: Male