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

Model Number	02.12.0006L
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2021: lot 1901829: (b)(4) items manufactured and released on 28-june-2019.Expiration date: 2024-06-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.1903537.Batch review performed on 27 may 2021: lot 1903537: (b)(4) items manufactured and released on 03-oct-2019.Expiration date: 2024-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0511fl tibial insert fixed sphere flex size 5/11 mm l (k140826) lot.183025.Batch review performed on 27 may 2021.Lot 183025: (b)(4) items manufactured and released on 02-july-2018.Expiration date: 2023-06-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting stiffness during flexion.The surgeon revised the femoral component, tibial tray and poly 1 year 6 months after the primary and the surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12015486
• Report Number: 3005180920-2021-00499
• Device Sequence Number: 4543692
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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: 2019
• 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): 06/17/2021

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: 06/16/2024
• Device Model Number: 02.12.0006L
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 1901829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/17/2021
• 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