MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R; KNEE FEMORAL IMPLANT

Catalog Number	02.12.0025R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on december 09th 2019: lot 1765556: 33 items manufactured and released on 09-jan-2018.Expiration date: 18.12.2022.No anomalies found related to the problem.To date, 27 items of the same lot have been already sold without any other similar reported event.Additional device involved batch reviews performed on december 09th 2019: gmk-sphere 02.12.0413fr tibial insert fixed sphere flex size 4/13 mm r (k140826) lot 176181: 25 items manufactured and released on 16-jan-2018.Expiration date: 21.12.2022.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot 182906: 104 items manufactured and released on 14-sep-2018.Expiration date: 12.09.2023.No anomalies found related to the problem.To date, 100 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed due to infection, 1 year after primary.All hardware has been revised.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R
• Common Device Name: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9449585
• Report Number: 3005180920-2019-01059
• Device Sequence Number: 2973272
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• 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: 2018
• 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): 12/11/2019

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: 12/18/2022
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 176556
• 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: 12/11/2019
• 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: 79 YR
• Patient Weight: 80