MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 1+ L; FEMORAL CEMENTED COMPONENT

Model Number	02.12.0021L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 may 2021: lot 171803: (b)(4) items manufactured and released on 24-aug-2017.Expiration date: 2022-07-24.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.Another device involved: batch review performed on 07 may 2021: gmk-sphere 02.12.0210fl tibial insert fixed sphere flex #2/10 mm l (k121416), lot 2000384: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-18.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
The patient came in reporting knee pain and stiffness.The cause of the knee pain and stiffness is unknown.5 months after primary the surgeon revised the femoral component and insert and added an extension stem.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 1+ L
• Common Device Name: FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11877173
• Report Number: 3005180920-2021-00415
• Device Sequence Number: 3589507
• Product Code: JWH
• UDI-Device Identifier: 07630030862519
• UDI-Public: 07630030862519
• 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: 2020
• Device Explanted Year: 2021
• 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): 05/25/2021

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: 07/24/2022
• Device Model Number: 02.12.0021L
• Device Catalogue Number: 02.12.0021L
• Device Lot Number: 171803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/25/2021
• 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