MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R; FIXED TIBIAL INSERT

Model Number	02.12.0513FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 6 april 2020: lot 180415: (b)(4) items manufactured and released on 25-may-2018.Expiration date: 2023-05-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Additional implant involved: gmk-sphere 02.12.0006r femoral component sphere cemented size 6 r (k121416) lot.1901857.Batch review performed by medacta regualtory affairs department on 6 april 2020: lot 1901857: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Additional implant involved: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.1903518.Batch review performed by medacta regualtory affairs department on 6 april 2020: lot 1903518: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Additional implant involved: gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.1903586.Batch review performed by medacta regualtory affairs department on 6 april 2020: lot 1903586: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 2024-06-16.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 or Problem Description
The patient came in after 5 months from the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted spacer with antibiotic cement.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM R
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9989994
• Report Number: 3005180920-2020-00251
• Device Sequence Number: 13647465
• Product Code: JWH
• UDI-Device Identifier: 07630030862670
• UDI-Public: 07630030862670
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: 05/03/2023
• Device Model Number: 02.12.0513FR
• Device Catalogue Number: 02.12.0513FR
• Device Lot Number: 180415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/23/2020
• 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