MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; FEMUR SPHERE CEMENTED LEFT, SIZE 5+

Model Number	02.12.0025L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 years and 2 months after primary, 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
Batch review performed on 08-may-2025.Lot 162669: (b)(4) items manufactured and released on 20-may-2016.Expiration date: 09-may-2021.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 and revised: batch review performed on 08-may-2025.Gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 164914: (b)(4) items manufactured and released on 21-nov-2016.Expiration date: 07-nov-2021.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.Gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 165774: (b)(4) items manufactured and released on 10-nov-2016.Expiration date: 27-oct-2021.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 02.07.0036rp patella resurfacing size 4 (k113571) lot 166115: (b)(4) items manufactured and released on 25-nov-2016.Expiration date: 13-nov-2021.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.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: FEMUR SPHERE CEMENTED LEFT, SIZE 5+
• 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: 22114074
• Report Number: 3005180920-2025-00470
• Device Sequence Number: 17931296
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• 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): 05/30/2025

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 Expiration Date: 05/09/2021
• Device Model Number: 02.12.0025L
• Device Lot Number: 162669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2025
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2016
• 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: 74 YR
• Patient Sex: Male