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

Model Number	02.12.0004R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 october 2024.Lot: 1910662: (b)(4) items manufactured and released on 26-mar-2020.Expiration date: 2025-03-17.No anomalies found related to the problem.To date, all the items of the same lot have been sold with one similar reported event during the period of review.Additional component involved in the event: batch review performed on 07 october 2024.Gmk-sphere 02.12.0414fr tibial insert fixed sphere flex size 4/14 mm r (k121416) lot: 175261: (b)(4) items manufactured and released on 07-dec-2017.Expiration date: 2022-11-23.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in reporting laxity of the knee and the cause is unknown.At about 4 years and 2 months after the primary surgery, the surgeon revised the femur (with a posterior stabilized revision femoral component) and insert (from 14mm to 17mm and semi constrained).The surgery was completed successfully.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 20555190
• Report Number: 3005180920-2024-00870
• Device Sequence Number: 3250859
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 10/29/2024

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: 03/17/2025
• Device Model Number: 02.12.0004R
• Device Lot Number: 1910662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2020
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White