MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

Model Number	02.12.0003L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29.09.2021: lot 2010159: (b)(4) items manufactured and released on 27-nov-2020.Expiration date: 2025-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Other devices involved: batch review performed on 29.09.2021: gmk-sphere 02.07.0682l revision fixed tibial tray cemented size 2 l (k123721) lot 182075: (b)(4) items manufactured and released on 5-jun-2018.Expiration date: 2023-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Gmk-sphere 02.09.Ta205 tibial augmentation size 2/5mm (k130299) lot 172049: (b)(4) items manufactured and released on 3-may-2017.Expiration date: 2022-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Gmk-sphere 02.09.Ta205 tibial augmentation size 2/5mm (k130299) lot 2000750: (b)(4) items manufactured and released on 10-mar-2020.Expiration date: 2025-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.Gmk-sphere 02.12.0214fl tibial insert fixed sphere flex size 2/14 mm l (k121416) lot 168302: (b)(4) items manufactured and released on 10-feb-2017.Expiration date: 2022-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.
Event or Problem Description
4 months after the primary surgery the patient came in reporting looseness in the knee (loose ligaments).The surgeon decided to convert the patient to a hinge knee.The surgery was completed successfully.

• Brand Name: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12631243
• Report Number: 3005180920-2021-00806
• Device Sequence Number: 17215985
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/14/2021

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: 11/18/2025
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 2010159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/14/2021
• 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: Other