MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R; KNEE FEMORAL CEMENTED COMPONENT

Model Number	02.12.0006R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 2 years and 5 months post primary for femur and tibia loosening.All the devices have been revised successfully.
Additional Manufacturer Narrative
Batch review performed on 31 august 2022: lot 1907920: (b)(4) items manufactured and released on 13-nov-2019.Expiration date: 2024-11-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved component: batch review performed on 31 august 2022 on gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.1909611 lot 1909611: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R
• Common Device Name: KNEE FEMORAL CEMENTED COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15473602
• Report Number: 3005180920-2022-00713
• Device Sequence Number: 14171458
• Product Code: JWH
• UDI-Device Identifier: 07630030825880
• UDI-Public: 07630030825880
• 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: 2020
• Device Explanted Year: 2022
• 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): 09/22/2022

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: 11/02/2024
• Device Model Number: 02.12.0006R
• Device Catalogue Number: 02.12.0006R
• Device Lot Number: 1907920
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female