MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERIKA CEMENTLESS; GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6+R

Model Number	02.12.KA176R
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in presenting pain and the cause is unknown.The surgeon originally planned a liner swap and patella replacement, however during the revision the surgeon suspected the femur of being loose.So, at about 7 months from primary the surgeon revised the gmk-spherika implants to hinge implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 08 october 2025: lot 2402439: (b)(4) items manufactured and released on 10-july-2024.Expiration date: 2029-jun-25.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.Conclusion: 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 SPHERIKA CEMENTLESS
• Common Device Name: GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S6+R
• 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: 23334294
• Report Number: 3005180920-2025-01026
• Device Sequence Number: 9937525
• Product Code: MBH
• UDI-Device Identifier: 07630345799395
• UDI-Public: 07630345799395
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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.KA176R
• Device Lot Number: 2402439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 129 KG