MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L; KNEE CEMENTED TIBIAL TRAY

Catalog Number	02.07.1205L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision for cemented tibial tray subsidence at 6 years and 9 months post-primary.The tibia implanted during primary was undersized.Gmk hinge implanted successfully.
Additional Manufacturer Narrative
Batch review performed on 24 july 2023: lot 160576: 64 items manufactured and released on 23-mar-2016.Expiration date: 2021-03-09.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs department: 7 years after cemented primary tka the tibia subsides and needs revision.According to report, the primary component was undersized and then subsided.Subsidence is visible on the one radiograph made available, but the quality of the picture and the orientation of the shot do not allow any furtehr conclusion to be made.However, there's no indication that the report of undersized component was untrue.We do not know when the subsidence took place because no radiographic or clinical history was supplied.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
• Common Device Name: KNEE CEMENTED 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: 17458441
• Report Number: 3005180920-2023-00622
• Device Sequence Number: 7190061
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• 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: 2016
• 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): 08/04/2023

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: 03/09/2021
• Device Catalogue Number: 02.07.1205L
• Device Lot Number: 160576
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2016
• 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: Male