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

Model Number	02.12.0025L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 07.08.2020: lot 171809: (b)(4) items manufactured and released on 12-jun-2017.Expiration date: 2022-06-27.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 items involved in the event, batch review performed on 07.08.2020: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.170430.Lot 170430: (b)(4) items manufactured and released on 20-jun-2017.Expiration date: 2022-06-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.Gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot.162488.Lot 162488: (b)(4) items manufactured and released on 28-jun-2016.Expiration date: 2021-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.Gmk-sphere 02.07.F11030 primary extension stem ø11mm / l 30 mm (k133630) lot.175532.Lot 175532: (b)(4) items manufactured and released on 24-oct-2017.Expiration date: 2022-10-11.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 02.12.0512fl tibial insert fixed sphere flex #5/12 mm l (k121416) lot.1811464.Lot 1811464: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-03-10.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.
Event or Problem Description
The patient came in after 5 months from the last revision surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and removed all components and implanted new components the surgery was completed successfully.This patient had 2 revision surgery previously due to an infection where only the insert was swapped (for both cases).This revision surgery happened 2 years and 7 months after primary surgery.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10458489
• Report Number: 3005180920-2020-00558
• Device Sequence Number: 2147262
• Product Code: JWH
• UDI-Device Identifier: 07630030862410
• UDI-Public: 07630030862410
• 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 Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 06/27/2022
• Device Model Number: 02.12.0025L
• Device Catalogue Number: 02.12.0025L
• Device Lot Number: 171809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/27/2020
• 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