MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0026R
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2021: lot 183465: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Another device involved: batch review performed on 14 may 2021: gmk-sphere 02.12.0610fr tibial insert fixed sphere flex size 6/10 mm r (k121416) lot 183072: (b)(4) items manufactured and released on 28-jun-2018.Expiration date: 2023-06-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting discomfort and tightness in the knee and the cause of the discomfort and tightness is unknown.The surgeon revised the femoral component, insert, and added an extension stem and offset connector 2 years and 6 months after primary.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11946022
• Report Number: 3005180920-2021-00477
• Device Sequence Number: 19104092
• Product Code: JWH
• UDI-Device Identifier: 07630030862441
• UDI-Public: 07630030862441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 06/07/2021

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: 06/27/2023
• Device Model Number: 02.12.0026R
• Device Catalogue Number: 02.12.0026R
• Device Lot Number: 183465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/07/2021
• 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