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

Model Number	02.12.0024L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 march 2021: lot 178021: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-09.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 19 march 2021.Gmk-sphere 02.12.0411fl tibial insert fixed sphere flex #4/11 mm l (k140826)lot.175241: (b)(4) items manufactured and released on 10-oct-2017.Expiration date: 2022-09-28.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 2 years and 9 months after the primary surgery reporting instability and the cause of the instability is unknown.The surgeon revised the femoral component and insert, and added an extension stem and femoral distal wedge.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11633971
• Report Number: 3005180920-2021-00271
• Device Sequence Number: 11649276
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• 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): 04/08/2021

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: 01/09/2023
• Device Model Number: 02.12.0024L
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 178021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/08/2021
• 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