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

Model Number	02.12.0004R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 187147: (b)(4) items manufactured and released on 15-nov -2018.Expiration date: 2023-11-05.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 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.189152.Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 189152: (b)(4) items manufactured and released on 08-feb-2019.Expiration date: 2024-01-30.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 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.189050.Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 189050: (b)(4) items manufactured and released on 04-mar-2019.Expiration date: 2024-02-19.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.Additional implant involved: gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot.1810564.Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1810564: (b)(4) items manufactured and released on 20-feb-2019.Expiration date: 2024-02-05.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.
Event or Problem Description
The patient came in 1 year and 1 month after the primary due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10300534
• Report Number: 3005180920-2020-00465
• Device Sequence Number: 13582065
• Product Code: JWH
• UDI-Device Identifier: 07630030825842
• UDI-Public: 07630030825842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 11/05/2023
• Device Model Number: 02.12.0004R
• Device Catalogue Number: 02.12.0004R
• Device Lot Number: 187147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/21/2020
• 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