MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 L; KNEE FEMUR CEMENTED

Model Number	02.12.0003L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 january 2020: lot 1811337: (b)(4) items manufactured and released on 15-mar-2019.Expiration date: 2024-03-04.No anomalies found related to reported problems.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.Additional devices involved: batch reviews performed on 22 january 2020: gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 1810457: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-03-13.No anomalies found related to reported problems.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.Gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot 176149: (b)(4) items manufactured and released on 29-dic-2017.Expiration date: 2022-12-10.No anomalies found related to reported problems.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2017.Gmk-sphere 02.07.0033rp patella resurfacing size 1 (k090988) lot 180308: (b)(4) items manufactured and released on 8-may-2018.Expiration date: 2023-04-25.No anomalies found related to reported problems.To date, (b)(4) items of the same lot have been already sold with one similar reported event since 2017.Preliminary investigation performed by medacta r&d knee project manager: the pictures provided show the femoral component and the tibial tray covered by biological fluids, as expected after implant removal.Based on the available information it is not possible to state any implant's related failure root cause.
Event or Problem Description
The patient came in 1 year and 6 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3 L
• Common Device Name: KNEE FEMUR CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11300310
• Report Number: 3005180920-2021-00091
• Device Sequence Number: 20082904
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2021

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: 03/04/2024
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 1811337
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/09/2021
• 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