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

Model Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 july 2019: lot 166914: (b)(4) items manufactured and released on 16.01.2017.Expiration date: 2022-01-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
Revision surgery performed after 1 year and 11 months after the primary due to signs of an infection (the pathogen is unknown).The surgeon removed all implants and implanted a femoral component, tibial insert and cement spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Additional implant involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r lot: 170442 batch review performed on 19 july 2019: lot: 170442: (b)(4) items manufactured and released on 04.05.2017.Expiration date: 2022-04-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.12.0412fr tibial insert fixed sphere flex size 4/12 mm r lot: 168356.Batch review performed on 19 july 2019: lot: 168356: (b)(4) items manufactured and released on 07.03.2017.Expiration date: 2022-02-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.0035rp patella resurfacing size 3 lot: 171209.Batch review performed on 19 july 2019: lot: 171209: (b)(4) items manufactured and released on 19.05.2017.Expiration date: 2022-05-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.On 31-jan-2020, we were informed that on (b)(6) 2020 the patient had permanent hardware implanted after infection.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8835136
• Report Number: 3005180920-2019-00643
• Device Sequence Number: 19518670
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 01/01/2022
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 166914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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