MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R; KNEE CEMENTED FEMORAL COMPONENT TINBN COATED

Catalog Number	02.12.0703R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At 11 months from the primary, the patient came in reporting pain due to a loose femoral component and tibial tray.The surgeon revised the femoral component, insert and tibial tray and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 05 december 2023.Lot 2204114: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-06-14.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported event during the period of review.Additional involved implant.Batch review performed on 05 december 2023 on gmk-sphere 02.07.2802r tibial tray fixed cemented size 2 r tinbn coated (k202684) lot.2214171.Lot 2214171: (b)(4) items manufactured and released on 22-nov-2022.Expiration date: 2027-11-07.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT TINBN COATED
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18380468
• Report Number: 3005180920-2023-01025
• Device Sequence Number: 7766954
• Product Code: JWH
• UDI-Device Identifier: 07630040711418
• UDI-Public: 07630040711418
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/21/2023

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 Catalogue Number: 02.12.0703R
• Device Lot Number: 2204114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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