MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; KNEE CEMENTED FEMUR

Catalog Number	02.12.0006L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2024: lot 1906027: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 2024-10-09.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had primary knee surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in reporting pain due to a tibial subsidence.The cause of the tibial subsidence is unknown.The surgeon revised the tibial tray, insert, and implanted tibial augments, an offset connector, and a fluted extension stem.The surgery was completed successfully.On (b)(6) 2024, the patient came in reporting pain due to a loose femur and the cause is unknown.The surgeon revised the femur and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 20155190
• Report Number: 3005180920-2024-00729
• Device Sequence Number: 19895441
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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: 2021
• 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): 09/06/2024

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: 10/09/2024
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 1906027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• 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: 61 YR
• Patient Sex: Male