MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE PATELLA RESURFACING SIZE 2; PATELLAR IMPLANT

Model Number	02.07.0034RP
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2021: lot 189225: (b)(4) items manufactured and released on 09-jan-2019.Expiration date: 2023-12-13.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Additional implant involved: gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l (k140826) lot.1901870.Batch review performed on 25 march 2021: lot 1901870: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-24.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 implant involved: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot.1904219.Batch review performed on 25 march 2021: lot 1904219: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 2024-10-02.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 implant involved: gmk-sphere 02.12.0412crl tibial insert fixed sphere cr size 4/12 mm l (k181635) lot.185590.Batch review performed on 25 march 2021: lot 185590: (b)(4) items manufactured and released on 16-oct-2018.Expiration date: 2023-10-02.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
The patient came in 1 year and 2 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised all components with competitor hardware.The surgery was completed successfully.

• Brand Name: GMK-SPHERE PATELLA RESURFACING SIZE 2
• Common Device Name: PATELLAR IMPLANT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11568009
• Report Number: 3005180920-2021-00238
• Device Sequence Number: 3599293
• Product Code: JWH
• UDI-Device Identifier: 07630030815751
• UDI-Public: 07630030815751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 12/13/2023
• Device Model Number: 02.07.0034RP
• Device Catalogue Number: 02.07.0034RP
• Device Lot Number: 189225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/25/2021
• 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