MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0003R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-jun-2020: lot 187144: (b)(4) items manufactured and released on 26-oct-2018.Expiration date: 11-oct-2023.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.Other device involved in the event: gmk-sphere 02.12.0314fr tibial insert fixed sphere flex size 3/14 mm r lot.1811491 (k121416).Batch review performed on 23-jun-2020: lot 1811491: (b)(4) items manufactured and released on 09-apr-2019.Expiration date: 23-mar-2024.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 due to signs of infection 6 months after the primary, the pathogen is unknown.The surgeon performed an i&d and revised the femoral component and poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10194001
• Report Number: 3005180920-2020-00364
• Device Sequence Number: 2973857
• Product Code: JWH
• UDI-Device Identifier: 07630030825828
• UDI-Public: 07630030825828
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: No Information
• Device Expiration Date: 10/11/2023
• Device Model Number: 02.12.0003R
• Device Catalogue Number: 02.12.0003R
• Device Lot Number: 187144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/25/2020
• 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
• Patient Age: 61 YR