MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R

Model Number	02.12.0003R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery after 9 years and 7 months due to persistent instability.Intraoperative findings revealed no evidence of implant loosening or infection, and the procedure was completed without complications.The surgeon revised all medacta implants.
Additional Manufacturer Narrative
Batch review performed on 13 may 2026 gmk-sphere 02.12.0003r gmk-sphere femoral component cemented - 3r (k121416) lot.152876: (b)(4) items manufactured and released on 14 july 2015.Expiration date: 31 may 2020.No anomalies found related to the problem.To date, 59 items of the same lot have been sold, with no similar reported events during the period of review.Gmk-sphere 02.07.1203r tibial tray fix cemented s.3r (k090988) lot.152809: (b)(4) items manufactured and released on 24 september 2015.Expiration date: 31 august 2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Gmk-sphere 02.12.0310fr gmk-sphere tibial insert - flex s3r - 10 mm lot.153768: (b)(4) items manufactured and released on 04 november 2015.Expiration date: 18 october 2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold, with no similar reported events during the period of review.Clinical evaluation this case describes a late failure of a revision total knee arthroplasty, characterized by pain and progressive instability associated with medial collateral ligament (mcl) and posterior cruciate ligament (pcl) incompetence.Radiographic findings show limited radiolucent lines at the tibial interface, without evidence of gross migration.Although such findings may be suggestive of interface changes, the available clinical information explicitly reports absence of implant loosening.From standard radiographic images no inference can be made on the status of the soft tissue.The overall clinical picture is most consistent with a well-known complication following total knee arthroplasty, namely instability.This condition may develop over time as a consequence of progressive soft tissue insufficiency, with ligamentous structures potentially stretching or becoming incompetent, leading to inadequate joint stability.Based on the available information, there is no evidence to suggest a device malfunction or manufacturing defect.The root cause is most likely multifactorial, predominantly related to ligamentous failure and long-term biomechanical changes.Root cause: knee instability is a known possible complication following primary knee arthroplasty, often related to natural soft tissue degradation.Although no definitive root cause can be established, there is no indication that any device-related issue caused or contributed to the event.In addition, the documentation review did not identify any potential manufacturing-related cause.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R
• 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: 25160332
• Report Number: 3005180920-2026-00425
• Device Sequence Number: 21506544
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• Combination Product (Y/N): N
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 05/13/2026

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 Expiration Date: 05/31/2020
• Device Model Number: 02.12.0003R
• Device Lot Number: 152876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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: 70 YR
• Patient Sex: Unknown