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

Model Number	02.12.0022L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient came in reporting pain and stiffness and the cause is unknown.The surgeon revised the femur and insert and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 august 2022.Lot 2110068: 12 items manufactured and released on 02-dec-2021.Expiration date: 2026-nov-18.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported event during the period of review.Other component involved: gmk-sphere 02.12.0211fl tibial insert fixed sphere flex size 2/11 mm l (k140826) lot.171040: 30 items manufactured and released on 24-may-2017.Expiration date: 2022-may-10.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15247648
• Report Number: 3005180920-2022-00615
• Device Sequence Number: 14905060
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/18/2022

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 Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 2110068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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