MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0004L
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); Implant Pain (4561)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 years and 5 months from the primary, the patient came in reporting pain and instability and the cause is unknown.The surgeon opened up the patient and observed that both the tibial tray and femoral component were loose.The cause of the loose implants is unknown.The surgeon revised the femoral component, tibial tray, and poly with competitor components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 1906836: 31 items manufactured and released on 07-nov-2019.Expiration date: 2024-10-22.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.Other devices involved: gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3-i4 l (k121416) lot 1904613: 50 items manufactured and released on 25-sept-2019.Expiration date: 2024-09-11.No anomalies found related to the problem.To date, all items of the same lot have been sold with another similar reported event during the period of review.Gmk-sphere 02.12.0414fl tibial insert fixed sphere flex size 4/14 mm l (k121416) lot 184217: 25 items manufactured and released on 18-jul-2018.Expiration date: 2023-07-04.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE 02.12.0004L 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
• 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: 18148921
• Report Number: 3005180920-2023-00889
• Device Sequence Number: 7502897
• Product Code: JWH
• UDI-Device Identifier: 07630030825835
• UDI-Public: 07630030825835
• 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: 2023
• 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): 11/16/2023

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: 10/22/2024
• Device Catalogue Number: 02.12.0004L
• Device Lot Number: 1906836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2019
• 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 Sex: Female
• Patient Race: White