MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0004L
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 april 2019: lot 180947: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2019 we were informed about a patient who would have needed a revision due to pain and suspected femoral component loosening.The revision was performed on (b)(6) 2019: the surgeon revised the femoral component (confirmed to be loose) and poly but did not revise the tibial tray.The poly was revised only for prophylaxis.The surgery was completed successfully.The patient had a primary tka on (b)(6) 2015 and had been already revised due to laxity on (b)(6) 2018 (tibial tray, femoral component and poly were revised - complaint (b)(4)).

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522873
• Report Number: 3005180920-2019-00291
• Device Sequence Number: 2689450
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

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: 05/16/2023
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 180947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention