MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L; KNEE TIBIAL TRAY

Catalog Number	02.07.1201L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2023 lot 103277: (b)(4) items manufactured and released on 03-nov-2010.Expiration date: 2015-09-30; 2 items reworked and released on 15-sep-2016.Expiration date: 2021-08-28.No anomalies found related to the problem.Additional implant involved, batch review performed on 13 december 2023: gmk-sphere 02.12.0110fl tibial insert fixed sphere flex size 1/10 mm l (k121416) lot 187201: 30 items manufactured and released on 22-jan-2019.Expiration date: 2024-01-02.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery due to tibial tray fixed cemented size 1 subsidence and knee instability, at about 2 years 10 months after the primary.All components successfully revised with competitor's system.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 L
• Common Device Name: KNEE 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: 18334828
• Report Number: 3005180920-2023-01011
• Device Sequence Number: 8406511
• Product Code: JWH
• UDI-Device Identifier: 07630030819841
• UDI-Public: 07630030819841
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/15/2023

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 Expiration Date: 08/28/2021
• Device Catalogue Number: 02.07.1201L
• Device Lot Number: 103277
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: Unknown