MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE SPHERIKA FEMURS; GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED

Model Number	02.12.KA12R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 oct 2025.Gmk-spherika 02.12.Ka12r gmk spherika femoral component s2+r cemented (k211004) lot: 2425948: (b)(4) items manufactured and released on 25-nov-2024.Expiration date: 2029-nov-12.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 02.07.1202r tibial tray fix cemented s.2r (k090988) lot: 2431545: (b)(4) items manufactured and released on 23-jan-2025.Expiration date: 2030-jan-08.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 02.12.0210fr gmk-sphere tibial insert - flex s2r - 10 mm (k121416) lot: 2433300: (b)(4) items manufactured and released on 03-jan-2025.Expiration date: 2029-12-15.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.Investigation performed by r& d project manager.A revision procedure was performed six weeks after the primary implantation due to reported instability.Based on the photographic evidence provided, no residual cement was visible on the distal surface of the explanted tibial baseplate.This observation is consistent with findings occasionally noted in retrieved components, including cases where the revision is not associated with instability, loosening, or implant mobilization.Therefore, the absence of cement on the distal surface cannot be considered indicative of insufficient adhesion between the cement and the implant.The surface finish of the tibial baseplate, as observed in the available images, appears consistent with the device specifications.No visible signs of manufacturing nonconformity can be identified from the photographs.The reported loosening may be attributable to factors unrelated to the device itself, such as cement failure, suboptimal cementation technique, or patient-specific clinical conditions.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.
Event or Problem Description
At 6 weeks from primary surgery (h_mar_rsk_dj_24011951), multidirectional instability was detected.No trauma reported.During revision surgery, the tibial tray could be explanted by hand, with no bonding with cement.Hinge system successfully implanted.The patient has implant cast megaprosthesis.

• Brand Name: GMK-SPHERE SPHERIKA FEMURS
• Common Device Name: GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED
• 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: 23579963
• Report Number: 3005180920-2025-01121
• Device Sequence Number: 9398192
• Product Code: JWH
• UDI-Device Identifier: 07630345716200
• UDI-Public: 07630345716200
• Combination Product (Y/N): N
• PMA/510(K) Number: K211004
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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.KA12R
• Device Lot Number: 2425948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2024
• 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: 74 YR
• Patient Sex: Unknown