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

Model Number	02.12.0006R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 september 2024: 02.12.0006r femoral component sphere cemented size 6 r lot 140304: (b)(4) items manufactured and released on 17-feb-2014.Expiration date: 2019-01-31.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 components involved: batch review performed on 19 september 2024: ref.02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.133916: (b)(4) items manufactured and released on 03-feb-2014.Expiration date: 2018-08-31.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.Batch review performed on 20 september 2024: ref.02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.140176: (b)(4) items manufactured and released on 17-mar-2014.Expiration date: 2019-02-28.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.Batch review performed on 20 september 2024: ref.02.12.0510fr tibial insert fixed sphere flex size 5/10 mm r (k121416) lot.140360: (b)(4) items manufactured and released on 13-feb-2014.Expiration date: 2019-01-31.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.
Event or Problem Description
First stage knee revision for infection at about 10 years and 3 months post primary.All implants were removed and washout was performed.A competitor spacer was implanted as the joint was infected.After a check of the agent with the hospital, no further information will be available regarding the 2nd stage revision or the patient.

• 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: 20448872
• Report Number: 3005180920-2024-00813
• Device Sequence Number: 15586521
• Product Code: JWH
• UDI-Device Identifier: 07630030825880
• UDI-Public: 07630030825880
• 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: 2014
• Device Explanted Year: 2024
• 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): 10/15/2024

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: 01/31/2019
• Device Model Number: 02.12.0006R
• Device Lot Number: 140304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2014
• 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: Female