MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

Model Number	02.12.0025L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2025.Lot: 174837: (b)(4) items manufactured and released on 20-nov-2017.Expiration date: 2022-11-01.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 performed by clinical affairs department: 7 years after primary cemented tka on a heavy male patient, the femoral component is radiographically loose and revision is undertaken.During surgery, the tibial tray also comes off easily.No cement is attached to either component.This, along with the radiographic appearance, suggests that a cementation problem may have occurred at index surgery, even though the duration of the replacement is unusually long, for cases with cement anomalies.No definitive conclusion can be reached with the information at hand.Additional implants revised: gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k090988) lot: 171866 batch review performed on 14 january 2025.(b)(4) items manufactured and released on 29-nov-2017.Expiration date: 2022-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one 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 investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery for knee loosening at about 6 years and 10 months post-primary due to femoral loosening.During the revision, it was found that the tibial implant was loose too.There were no signs of cement on the revised implants.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
• 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: 21321420
• Report Number: 3005180920-2025-00016
• Device Sequence Number: 7918501
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/06/2025

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: 11/01/2022
• Device Model Number: 02.12.0025L
• Device Lot Number: 174837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2017
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White