MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R

Catalog Number	02.07.1202R
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-aug-2024 lot 2007316: (b)(4) items manufactured and released on 05-oct-2020.Expiration date: 2025-09-24.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional info involved, batch review performed on 09-aug-2024 gmk-sphere 02.12.0023r femoral component sphere cemented size 3+ r (k140826) lot 2003249: (b)(4) items manufactured and released on 15-jul-2020.Expiration date: 2025-jul-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 3 years and 7 months after primary, the patient has been revised due to femoral and tibial tray mobilization.All implants revised successfully to competitor's system.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 R
• Common Device Name: TIBIAL TRAY
• 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: 20154931
• Report Number: 3005180920-2024-00685
• Device Sequence Number: 14512309
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/07/2024

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: 09/24/2025
• Device Catalogue Number: 02.07.1202R
• Device Lot Number: 2007316
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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
• Patient Weight: 60 KG