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

Model Number	02.12.0005L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 jun 2019: lot 160982: (b)(4) items manufactured and released on 04-apr-2016.Expiration date: 2021-03-06.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.Additional implant involved: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988), lot 155594: (b)(4) items manufactured and released on 28-dec-2015.Expiration date: 2020-12-07.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any other similar reported event.Gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416), lot 160598: (b)(4) items manufactured and released on 09-may-2016.Expiration date: 2021-04-18.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 02.07.0035rp patella resurfacing size 3 (k090988), lot 160954: (b)(4) items manufactured and released on 26-apr-2016.Expiration date: 2021-04-13.No anomalies found related to the problem.To date, all the 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 2 years and 10 months after primary, the pathogen is unknown.The surgeon performed a washout and explanted the femoral component, tibial tray, poly and patella.The surgeon implanted a temporary spacer and the surgery was completed successfully.
Additional Manufacturer Narrative
On the (b)(6) 2020 we were informed that: back on (b)(6) 2019, the patient had an infection and a spacer was implanted.This patient was implanted with permanent hardware today ((b)(6) 2020).

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8691457
• Report Number: 3005180920-2019-00453
• Device Sequence Number: 16555217
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 03/06/2021
• Device Model Number: 02.12.0005L
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 160982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/28/2020
• 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