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

Model Number	02.12.0024R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-feb-2020.Lot 173659: (b)(4) items manufactured and released on 11-oct-2018.Expiration date: 28.09.2022.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 devices involved in the event: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r lot.174563 (k090988).Batch review performed on 11-feb-2020.Lot 174563: (b)(4) items manufactured and released on 13-nov-2017.Expiration date: 02.11.2022.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.Gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r lot.171074 (k121416).Batch review performed on 11-feb-2020.Lot 171074: (b)(4) items manufactured and released on 23-may-2017.Expiration date: 08.05.2022.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 instability and the cause of the instability is unknown, 1 year and 10 months after primary.The surgeon revised the femoral component, inlay and tibial tray.The surgery was completed successfully.The inlay has been replaced with a 12 mm implant.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 4+ R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9698647
• Report Number: 3005180920-2020-00036
• Device Sequence Number: 2824776
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 173659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• 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