MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L; FEMORAL COMPONENT CEMENTED

Model Number	02.12.0022L
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 january 2020: lot 1811307:(b)(4) items manufactured and released on 10-apr-2019.Expiration date: 2024-03-20.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 since 1-1-2016.Other devices involved in the event: gmk-sphere 02.12.0210fl tibial insert fixed sphere flex size 2/10 mm l lot.188991 (k121416) batch review performed on 10 february 2020: lot 188991: (b)(4) items manufactured and released on 12-feb-2019.Expiration date: 2024-01-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported.Gmk-sphere 02.07.1202l tibial tray fixed cemented size 2 l lot.189124 (k090988).Batch review performed on 10 february 2020: lot 189124: (b)(4) items manufactured and released on 07-feb-2019.Expiration date: 2024-01-07.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 or Problem Description
The patient came in reporting pain due to ruptured patellar tendon.For the surgeon the event is due to femur cut performed in primary surgery.4 months after primary the surgeon revised the femoral component, insert, and tibial tray.The surgery was completed successfully.The patella was from competitor.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9698768
• Report Number: 3005180920-2020-00038
• Device Sequence Number: 11368281
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• 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): 02/12/2020

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: 03/20/2024
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 1811307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/12/2020
• 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