MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE CEMENTLESS; GMK SPHERE FEMUR POROUS TIGROWTHC+HA S6R

Model Number	02.12.1506R
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to femural and tibial components loosening at 2 years and 8 months.The surgeon revised all gmk-sphere implants (femoral component, insert, and tibial tray) and revised to gmk-revision implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 may 2026 gmk-sphere 02.12.1506r gmk sphere femur porous tigrowthc+ha s6r (k223548) lot.2245878: (b)(4) items manufactured and released on 06-jun-2023.Expiration date: 2028-may-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Gmk-sphere 02.12.3d05r gmk 3dmetal tibial tray size 5r (k221850) lot.2238284: (b)(4) items manufactured and released on 09-nov-2022.Expiration date: 2027-nov-01.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: GMK SPHERE CEMENTLESS
• Common Device Name: GMK SPHERE FEMUR POROUS TIGROWTHC+HA S6R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25268616
• Report Number: 3005180920-2026-00499
• Device Sequence Number: 9185534
• Product Code: MBH
• UDI-Device Identifier: 07630345799128
• UDI-Public: 07630345799128
• Combination Product (Y/N): N
• PMA/510(K) Number: K223548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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: 02.12.1506R
• Device Lot Number: 2245878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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