MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0022R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 6 years from the primary, the patient came in reporting pain due to a loose femur and the cause of the loose femur is unknown.The surgeon revised the femoral component and insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29 april 2024 lot 172753: (b)(4) items manufactured and released on 20-sept-2017.Expiration date: 2022-09-03.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R
• 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: 19389764
• Report Number: 3005180920-2024-00326
• Device Sequence Number: 6955596
• Product Code: JWH
• UDI-Device Identifier: 07630030862366
• UDI-Public: 07630030862366
• 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: 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): 05/24/2024

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: 09/03/2022
• Device Catalogue Number: 02.12.0022R
• Device Lot Number: 172753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2017
• 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 Sex: Unknown