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

Model Number	02.12.0026L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Aseptic loosening (4883)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years and 5 months from primary, the patient came in reporting pain due to a loose femur and the patella was not tracking well.The surgeon revised the femur, poly and patella.The liner was upsized from 12mm to 13mm to accommodate ligament laxity.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10-dec-2024: lot 1906048: (b)(4) items manufactured and released on 29-10-2019.Expiration date: 2024-10-15.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.Additional implants involved: batch review performed on 10-dec-2024 on gmk-sphere 02.12.0512fl tibial insert fixed sphere flex size 5/12 mm l (k121416) lot.1910176: lot 1910176: (b)(4) items manufactured and released on 19-12-2019.Expiration date: 2024-12-04.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.Batch review performed on 10-dic-2024 on gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot.1910555: lot 1910555: (b)(4) items manufactured and released on 05-02-2020.Expiration date: 2025-01-18.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.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.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE CEMENTED 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: 21026667
• Report Number: 3005180920-2024-01097
• Device Sequence Number: 9106961
• Product Code: JWH
• UDI-Device Identifier: 07630030862434
• UDI-Public: 07630030862434
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: 10/15/2024
• Device Model Number: 02.12.0026L
• Device Lot Number: 1906048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2019
• 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: 78 YR
• Patient Sex: Male