MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERIKA CEMENTLESS; GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S4R

Model Number	02.12.KA164R
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2025: lot 2346861: (b)(4) items manufactured and released on 19-jun-2024.Expiration date: 2029-06-04.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.Clinical evaluation by meadcta medical affairs manager: a revision surgery was performed 9 months after the implantation of a tka due to femoral component loosening.The available x-ray images clearly confirm the finding, showing radiolucent lines at the bone-implant interface.Given the relatively early occurrence of this failure, it is likely that osseointegration did not take place.Identifying an exact cause is challenging in this case, as the etiology is often multifactorial, potentially involving both the patient's biological characteristics and technical aspects of bone preparation and component implantation.Based on the current information, no definitive conclusions can be drawn.Root cause: aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
The surgeon observed that the femoral component had become loose as a result of the aseptic condition.At about 9 months post primary the surgeon revised the insert and the femoral component.The surgery was completed successfully.

• Brand Name: GMK SPHERIKA CEMENTLESS
• Common Device Name: GMK SPHERIKA FEMUR POROUS TIGROWTHC+HA S4R
• 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: 23336139
• Report Number: 3005180920-2025-00984
• Device Sequence Number: 9452439
• Product Code: MBH
• UDI-Device Identifier: 07630542702525
• UDI-Public: 07630542702525
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K223548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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.KA164R
• Device Lot Number: 2346861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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 Sex: Unknown