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

Catalog Number	02.12.0023R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2019.Lot 1901886: 50 items manufactured and released on 17-jun-2019.Expiration date: 2024-06-04.No anomalies found related to the problem.To date, 32 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0313fr tibial insert fixed sphere flex size 3/13 mm r (k140826) lot.175256.Batch review performed on 28 november 2019.Lot 175256: 30 items manufactured and released on 15-dec-2017.Expiration date: 2022-11-26.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.1203r tibial tray fixed cemented size 3 r (k090988) lot.1902703.Batch review performed on 28 november 2019.Lot 1902703: 53 items manufactured and released on 10-jul-2019.Expiration date: 2024-07-01.No anomalies found related to the problem.To date, 41 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager.Early infection in cemented tka, few weeks after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed, one month after primary surgery, due to infection.All components have been successfully revised.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9443713
• Report Number: 3005180920-2019-01055
• Device Sequence Number: 11285323
• Product Code: JWH
• UDI-Device Identifier: 07630030862380
• UDI-Public: 07630030862380
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 06/04/2024
• Device Catalogue Number: 02.12.0023R
• Device Lot Number: 1901886
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/10/2019
• 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: 82 YR